Identity
- Trade Name
- OTSC Proctology Anchor FDA UDI
- Generic Name
- Flexible endoscopic tissue manipulation forceps, single-use FDA UDI
- Device Name
- The OTSC Proctolgy Anchor is one of the OTSC application aids and can be used for treating a lesion before release of the OTSC Proctology clip • it can be used with the OTSC Proctology for grasping and manipulation of tissue in the anorectum • using when the application area of the OTSC Proctology clip cannot be reached with sutures • the head of the instrument is made of Nitinol FDA UDI
- Model / Reference
- 38 cm FDA UDI
- Description
- The OTSC Proctolgy Anchor is one of the OTSC application aids and can be used for treating a lesion before release of the OTSC Proctology clip • it can be used with the OTSC Proctology for grasping and manipulation of tissue in the anorectum • using when the application area of the OTSC Proctology clip cannot be reached with sutures • the head of the instrument is made of Nitinol FDA UDI
Identifiers
- Catalog Number
- 200.61 FDA UDI
- Primary DI / UDI-DI
- 04260206310273 FDA UDI
- FDA Product Code
- PTS FDA UDI
- GMDN Term
- Flexible endoscopic tissue manipulation forceps, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Flexible endoscopic tissue manipulation forceps, single-use
OTSC Proctology Anchor by Ovesco Endoscopy AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Flexible endoscopic tissue manipulation forceps, single-use.
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- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
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
- Ovesco Endoscopy AG
Sources (1)
- FDA UDI 68264501-b69f-4912-8e8e-cc764dc6bbd4 36 fields · synced Jun 6, 2026