Identity
- Trade Name
- Endochoice Drive Wire FDA UDI
- Generic Name
- Colonoscope stiffener FDA UDI
- Device Name
- When added scope stiffness is desired to negotiate a difficult colon, and prior to re positioning the patient, simply insert the Colonoscope Stiffening Device into the biopsy port to stiffen the insertion tube and advance to the cecum. The device is then withdrawn and the procedure is completed as usual. These reusable devices are compatible with Pentax ®, Fujinon®, Olympus® and Fuse® non-variable stiffness endoscopes. FDA UDI
- Model / Reference
- FSA-7501 FDA UDI
- Description
- When added scope stiffness is desired to negotiate a difficult colon, and prior to re positioning the patient, simply insert the Colonoscope Stiffening Device into the biopsy port to stiffen the insertion tube and advance to the cecum. The device is then withdrawn and the procedure is completed as usual. These reusable devices are compatible with Pentax ®, Fujinon®, Olympus® and Fuse® non-variable stiffness endoscopes. FDA UDI
Identifiers
- Catalog Number
- FSA-7501 FDA UDI
- Primary DI / UDI-DI
- 00817658020195 FDA UDI
- FDA Product Code
- FDF FDA UDI
- GMDN Term
- Colonoscope stiffener FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Endochoice Drive Wire by Zutron Medical, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Zutron Medical, L.l.c.
Sources (1)
- FDA UDI 1bce7ed0-6161-4bb9-9748-425729541b10 35 fields · synced Jun 8, 2026