Identity
- Trade Name
- Endocuff FDA UDI
- Generic Name
- Colonoscope distal anchoring cuff FDA UDI
- Device Name
- AEC130 Size 3 (S) Endocuff Sterile Purple- 1 pot - single unit FDA UDI
- Model / Reference
- AEC130 FDA UDI
- Description
- AEC130 Size 3 (S) Endocuff Sterile Purple- 1 pot - single unit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060423410102 FDA UDI
- FDA Product Code
- FED FDA UDI
- GMDN Term
- Colonoscope distal anchoring cuff 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 10.4 Millimeter FDA UDI
Category: Colonoscope distal anchoring cuff
Endocuff by Boddingtons Plastics, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Endocuff Vision — Boddingtons Plastics, Ltd. · Class II
- Endocuff Vision — Boddingtons Plastics, Ltd. · Class II
- Endocuff — Boddingtons Plastics, Ltd. · 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
- Boddingtons Plastics, Ltd.
Sources (1)
- FDA UDI b4a8620d-07a1-4850-8568-ebe7d68b6fb6 34 fields · synced May 30, 2026