Sofradim Production
Profile: Sofradim Production deals with endoscopic staplers, sterile surgical meshes and needles.
FDA Registration Number: 9615742
US Agent: Renee Borgesano / Covidien
Phone: +1-(203)-492-5325 Fax: +1-(203)-492-5029 E-Mail:
6 Products/Services (Click for related suppliers)
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| • Endoscopic Linear Staplers |
| • General & Plastic Surgery Laparoscope (FDA Code: GCJ / 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. |
| • 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. |
| • Polymeric Surgical Mesh (FDA Code: FTL / 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. |
| • Surgical Mesh (FDA Code: FTM / 878.3300) |
| • Surgical Mesh Systems |
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