Identity
- Trade Name
- CRW® FDA UDI
- Generic Name
- Stereotactic radiosurgical invasive head frame FDA UDI
- Device Name
- CRW® Precision Arc System Guide Block FDA UDI
- Model / Reference
- CRWPGB FDA UDI
- Description
- CRW® Precision Arc System Guide Block FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780251361 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
- 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
Ethylene Oxide FDA UDI
Category: Stereotactic radiosurgical invasive head frame
Crw® by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stereotactic radiosurgical invasive head frame.
- Head Frame Kit — Varian Medical Systems, Inc · Class II
- Head Frame - Post Assembly Set — Varian Medical Systems, Inc · Class II
- Head Frame Cranial Screws - Long and Short — Varian Medical Systems, Inc · Class II
- Headpins — Brainlab SE · Class II
- Headpins — Brainlab SE · Class II
- Cranial Screw - Short — Varian Medical Systems, Inc · Class II
- Cranial Screw - Short/Long — Varian Medical Systems, Inc · Class II
- Headpins — Brainlab SE · Class II
Cleared under the same submission
K944463 also covers:
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
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 Corp.
Sources (1)
- FDA UDI dbdcbea0-50ce-415c-9e16-31295e4c6d8a 35 fields · synced May 30, 2026