Identity
- Trade Name
- CODMAN HOLTER FDA UDI
- Generic Name
- Subcutaneous tunneller, reusable FDA UDI
- Device Name
- CODMAN HOLTER Introducer and Cone Set FDA UDI
- Model / Reference
- 82-1690 FDA UDI
- Description
- CODMAN HOLTER Introducer and Cone Set FDA UDI
Identifiers
- Catalog Number
- 821690 FDA UDI
- Primary DI / UDI-DI
- 10886704040705 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Subcutaneous tunneller, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5550 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Codman Holter by Cerenovus, Inc. — 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
- Cerenovus, Inc.
Sources (1)
- FDA UDI 1bb9a469-83ef-49bd-90b7-9215a9690481 36 fields · synced May 30, 2026