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Address: 515 Woodscrest Medical Bldg., Suite 001, P.o. Box 5504, Bloomington, Indiana 47407-5504, USA
Phone: +1-(812)-336-2567
Products: Endoscopic Binocular Attachment (FDA Code:
FEJ), ...
Manico Bloomington specializes in manufacturing endoscopic binocular attachments.
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Address: 14300 Wood Duck Lane, Colonial Heights, Virginia 23834, USA
Phone: +1-(877)-772-8378
FDA Registration: 3004057871
Products: Blood pressure Cuffs (FDA Code:
DXQ), Stethoscope Head (FDA Code:
BZS), Manual Stethoscope (FDA Code:
LDE), Endoscopic Binocular Attachment (FDA Code:
FEJ), ...
Medtex LLC is involved in the business of blood pressure cuffs, endoscopic binocular attachments, manual stethoscopes and stethoscope heads.
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Address: Pforzheimer Str. 32, Knittlingen 75438, Germany
www.richard-wolf.com |
Send Inquiry |
Phone: +49-(7043)-35-0
FDA Registration: 9611102 Employee Count: ~20
Products: Light Sources, Flexible, Stabilization and Steering, Endoscopic Carpal Tunnel Release Systems, Arthroscopes (FDA Code:
HRX), Cameras, ...
Richard Wolf GmbH develops endoscopes and modular system solutions for all medical fields. We are accredited with ISO9001 and ISO 13485 certification. Our nephroscopy is used to removal of kidney ston
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Address: Rudolf Diesel Ring 20, Sauerlach 82054, Germany
www.wisap.com |
Send Inquiry |
Phone: +49-(8104)-890-823
Annual Revenues: USD 25-50 Million
Employee Count: ~90
Quality: ISO 9001, CE Certified
Products: Arthroscopes (FDA Code:
HRX), Absorbable Suture Anchors, Absorbable Sutures (FDA Code:
GAK), Alligator Jaw-step Biopsy Forceps, Abdominal Retractor, Absorbable Suture Screwed Anchor, ...
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh offers equipment for gynecology,laparoscopy and pelviscopy besides disposable products. Our products include optics, tubing set, suture material, cat
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FDA Code / Regulation: FEJ / 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.
Classification. (1) Class II (performance standards).