Identity
- Trade Name
- CODMAN FDA UDI
- Generic Name
- Subcutaneous tunneller, single-use FDA UDI
- Device Name
- CODMAN Peel-Away Catheter Introducer 14 FR. FDA UDI
- Model / Reference
- 83-1326 FDA UDI
- Description
- CODMAN Peel-Away Catheter Introducer 14 FR. FDA UDI
Identifiers
- Catalog Number
- 831326 FDA UDI
- Primary DI / UDI-DI
- 20886704042744 FDA UDI
- 510(k) Number
- K883607 FDA UDI
- FDA Product Code
- GYK FDA UDI
- GMDN Term
- Subcutaneous tunneller, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 882.4545 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Codman by Cerenovus, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K883607 also covers:
- CODMAN® — Integra LifeSciences Production Corporation
- CODMAN® — Integra LifeSciences Production Corporation
- CODMAN® — Integra LifeSciences Production Corporation
- CODMAN® — Integra LifeSciences Production Corporation
- CODMAN® — Integra LifeSciences Production Corporation
- CODMAN® — Integra LifeSciences Production Corporation
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 I | Pending data |
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Manufacturer
- Manufacturer
- Cerenovus, Inc.
Sources (1)
- FDA UDI 03872109-ed91-4998-a4f1-699a77b1d0d9 37 fields · synced May 30, 2026