Identity
- Trade Name
- Integra® FDA UDI
- Generic Name
- Stereotactic radiosurgical invasive head frame FDA UDI
- Device Name
- Integra® UCHR ARC, Adaper Plate FDA UDI
- Model / Reference
- UCHRAP FDA UDI
- Description
- Integra® UCHR ARC, Adaper Plate FDA UDI
Identifiers
- Catalog Number
- UCHRAP FDA UDI
- Primary DI / UDI-DI
- 10381780252382 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
Yes
FDA UDI
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Category: Stereotactic radiosurgical invasive head frame
Integra® 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
K160811 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.
- Integra® — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI cf3d2ae3-816d-466e-81b5-0a44adee0a3b 36 fields · synced Jun 8, 2026