Identity
- Trade Name
- CODMAN® IPC EXPRESS® FDA UDI
- Generic Name
- Intracranial pressure monitor FDA UDI
- Device Name
- CODMAN® IPC EXPRESS® Power Supply 120/127 VAC 50-60HZ FDA UDI
- Model / Reference
- 826634 FDA UDI
- Description
- CODMAN® IPC EXPRESS® Power Supply 120/127 VAC 50-60HZ FDA UDI
Identifiers
- Catalog Number
- 82-6634 FDA UDI
- Primary DI / UDI-DI
- 10381780520443 FDA UDI
- 510(k) Number
- K945585 FDA UDI
- FDA Product Code
- GWM FDA UDI
- GMDN Term
- Intracranial pressure monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1620 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intracranial pressure monitor
Codman® Ipc Express® by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K945585 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
- CODMAN® — Integra LifeSciences Production Corporation
- CODMAN® — Integra LifeSciences Production Corporation
- CODMAN® — Integra LifeSciences Production Corporation
- CODMAN® IPC EXPRESS® — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI ef9f94d5-7655-48a0-b0ef-831646352579 37 fields · synced Jun 9, 2026