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CereLink™

FDA UDI

Class II (US FDA UDI)

by Integra LifeSciences Production Corporation

Identity

Trade Name
CereLink™ FDA UDI
Generic Name
Intracranial pressure monitor FDA UDI
Device Name
CereLink™ ICP Sensor Plastic Skull Bolt Kit for Intraparenchymal Procedure FDA UDI
Model / Reference
826852 FDA UDI
Description
CereLink™ ICP Sensor Plastic Skull Bolt Kit for Intraparenchymal Procedure FDA UDI

Identifiers

Catalog Number
82-6852 FDA UDI
Primary DI / UDI-DI
10381780520696 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

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

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Intracranial pressure monitor

CereLink™ by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intracranial pressure monitor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra LifeSciences Production Corporation

Sources (1)

  • FDA UDI 21c825d9-75ec-48fe-8974-c24f7191f425 36 fields · synced Jun 9, 2026