Identity
- Trade Name
- CODMAN® HOLTER® SALMON FDA UDI
- Generic Name
- Subcutaneous tunneller, reusable FDA UDI
- Device Name
- CODMAN® HOLTER® SALMON SALMON Distal Catheter Passer FDA UDI
- Model / Reference
- 821692 FDA UDI
- Description
- CODMAN® HOLTER® SALMON SALMON Distal Catheter Passer FDA UDI
Identifiers
- Catalog Number
- 82-1692 FDA UDI
- Primary DI / UDI-DI
- 10381780518051 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
- 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Subcutaneous tunneller, reusable
Codman® Holter® Salmon by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Subcutaneous tunneller, reusable.
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
- ELMED — ELMED INCORPORATED · Class I
- ELMED — ELMED INCORPORATED · Class I
- ELMED — ELMED INCORPORATED · Class I
- Natus® — Natus Medical Incorporated · Class I
- MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI 8ab5957e-056a-479c-ad43-44009f3a63a6 35 fields · synced Jun 9, 2026