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Crw®

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name
CRW® FDA UDI
Generic Name
Stereotactic radiosurgical invasive head frame FDA UDI
Device Name
CTCP for Phillips Scanner FDA UDI
Model / Reference
CTCPP FDA UDI
Description
CTCP for Phillips Scanner FDA UDI

Identifiers

Catalog Number
CTCPP FDA UDI
Primary DI / UDI-DI
10381780252542 FDA UDI
510(k) Number
K944463 FDA UDI
FDA Product Code
HAW FDA UDI
GMDN Term
Stereotactic radiosurgical invasive head frame FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Crw® by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K944463 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra Lifesciences Corp.

Sources (1)

  • FDA UDI c4220161-1efe-4c1e-b93a-e0c0f7dac332 37 fields · synced Jun 1, 2026