Identity
- Trade Name
- SUR-FIT LOOP OSTOMY ROD 65MM FDA UDI
- Generic Name
- Colostomy rod FDA UDI
- Device Name
- ConvaTec Loop Ost Rod 65Mm FDA UDI
- Model / Reference
- 022355 FDA UDI
- Description
- ConvaTec Loop Ost Rod 65Mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00768455115501 FDA UDI
- FDA Product Code
- EZP FDA UDI
- GMDN Term
- Colostomy rod FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4270 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 6.5 Centimeter FDA UDI
Category: Colostomy rod
Sur-Fit Loop Ostomy Rod 65mm by Convatec, Purchasing Department — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Colostomy rod.
- Barbell Loop Ostomy Device — TOOLS FOR SURGERY, LLC · Class II
- Bioseal Inc. — BIOSEAL · Class I
- Barbell Loop Ostomy Device — TOOLS FOR SURGERY, LLC · Class II
- Bioseal Inc. — BIOSEAL · Class I
- Coloplast — Coloplast A/S · Class II
- Barbell Loop Ostomy Device — TOOLS FOR SURGERY, LLC · Class II
- Hollister — Hollister Incorporated · Class II
- VISI-FLOW STOMA CONE — CONVATEC, PURCHASING DEPARTMENT · 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
- Convatec, Purchasing Department
Sources (1)
- FDA UDI 7161a81b-5ebc-4b4e-985e-bf2c7b5dd748 35 fields · synced May 29, 2026