Identity
- Trade Name
- DirectLink™ FDA UDI
- Generic Name
- Intracranial/compartmental-pressure monitor calibrator/cable FDA UDI
- Device Name
- DirectLink® ICP Extension Cable FDA UDI
- Model / Reference
- 826840 FDA UDI
- Description
- DirectLink® ICP Extension Cable FDA UDI
Identifiers
- Catalog Number
- 82-6840 FDA UDI
- Primary DI / UDI-DI
- 10381780520610 FDA UDI
- 510(k) Number
- K152670 FDA UDI
- FDA Product Code
- GWM FDA UDI
- GMDN Term
- Intracranial/compartmental-pressure monitor calibrator/cable 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
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
MR Unsafe FDA UDI
Category: Intracranial/compartmental-pressure monitor calibrator/cable
DirectLink™ by Integra LifeSciences Switzerland Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K152670 also covers:
- CODMAN® — Integra LifeSciences Switzerland Sàrl
- CODMAN® — Integra LifeSciences Switzerland Sàrl
- CODMAN® — Integra LifeSciences Switzerland Sàrl
- CODMAN® — Integra LifeSciences Switzerland Sàrl
- CODMAN® — Integra LifeSciences Switzerland Sàrl
- CODMAN® — Integra LifeSciences Switzerland Sàrl
- CODMAN® — Integra LifeSciences Switzerland Sàrl
- CODMAN® — Integra LifeSciences Switzerland Sàrl
- DirectLink™ — Integra LifeSciences Switzerland Sàrl
- DirectLink™ — Integra LifeSciences Switzerland Sàrl
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 Switzerland Sàrl
Sources (1)
- FDA UDI 04fe8693-b52a-4f7f-9701-6e27dc63d8d7 37 fields · synced May 30, 2026