Identity
- Trade Name
- Zutron Medical FDA UDI
- Generic Name
- Colonoscope stiffener FDA UDI
- Device Name
- The patented Endoscope Stiffening System (ESS) consists of the Colonoscope Stiffening Device and Enteroscope Stiffening Device.These are reusable devices that provide a simple way to temporarily stiffen the insertion tube of an endoscope during a procedure when difficult anatomy presents itself. They are compatible with Pentax ®, Fujinon®, and Olympus® non-variable stiffness endoscopes. FDA UDI
- Model / Reference
- ZUTR162000 FDA UDI
- Description
- The patented Endoscope Stiffening System (ESS) consists of the Colonoscope Stiffening Device and Enteroscope Stiffening Device.These are reusable devices that provide a simple way to temporarily stiffen the insertion tube of an endoscope during a procedure when difficult anatomy presents itself. They are compatible with Pentax ®, Fujinon®, and Olympus® non-variable stiffness endoscopes. FDA UDI
Identifiers
- Catalog Number
- ZUTR162000 FDA UDI
- Primary DI / UDI-DI
- 00817658020188 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
Zutron Medical 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 8a5efee5-d1c7-4a08-8ee3-df7a7adca808 35 fields · synced May 30, 2026