Carbon Medical Technologies, Inc.

Click Here To EMAIL INQUIRY
Contact: Robert Johnson - VP QA & Regulatory Affairs
Web: http://www.carbonmed.com
E-Mail:
Address: 1290 Hammond Road, Saint Paul, Minnesota 55110, USA
Phone: +1-(651)-653-8512, 877-277-1788 | Map/Directions >>

Profile: Carbon Medical Technologies, Inc. develops and manufactures carbon-coated implantable medical devices. The bio compatibility of carbon makes it an ideal implant agent for numerous applications, including soft tissue augmentation, tissue marking, and for vascular and neurological disorders. Our products are Durasphere® EXP, BiomarC®, Durasphere® GR and FI. The Durasphere GR is intended to treat problems associated with gastroesophageal reflux disease, and injectable bulking agent is composed of pyrolytic carbon-coated beads suspended in a water-based carrier gel. Our Durasphere EXP is indicated for the treatment of adults with stress urinary incontinence due to intrinsic sphincteric deficiency, or to treat vesicoureteral reflux. The BiomarC tissue marker is ideal for the radiographical marking of soft tissue at a surgical site during a surgical procedure, or for future surgical procedures. It is a sterile, MRI compatible marker, which is also visible under X-ray, mammography, fluoroscopy, and ultrasound.

The company was founded in 1994, has revenues of USD 5-10 Million, has ~10 employees and is ISO 9001, CE certified.

FDA Registration Number: 2134494

11 Products/Services (Click for related suppliers)

• Catheter Adaptor (FDA Code: GCE / 878.4200)

An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

• Embolic Injectable Agent (FDA Code: MFE)

• Endoscope Accessories (FDA Code: KOG)

• Fecal Incontinence Device

• Gastro-Urology Endoscopic Injection Needle (FDA Code: FBK / 876.1500)

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Gastroenterologic Needle Holder (FDA Code: FHQ / 876.4730)

A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

• Implantable Radiographic Marker (FDA Code: NEU / 878.4300)

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

• Implantable Staple (FDA Code: GDW / 878.4750)

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

• Injectable Bulking Agent (FDA Code: LNM)

• Surgical Mesh (FDA Code: FTM / 878.3300)

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

• Tissue Markers