Identity
- Trade Name
- VARIAN HEAD FRAME KIT FDA UDI
- Generic Name
- Stereotactic radiosurgical invasive head frame FDA UDI
- Model / Reference
- 2.0 FDA UDI
Identifiers
- Catalog Number
- P1006805003 FDA UDI
- Primary DI / UDI-DI
- 00899475002394 FDA UDI
- 510(k) Number
- K180586 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Stereotactic radiosurgical invasive head frame FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Stereotactic radiosurgical invasive head frame
Varian Head Frame Kit by Varian Medical Systems, Inc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Stereotactic radiosurgical invasive head frame.
- CRW® — Integra Lifesciences Corp. · Class II
- CRW® — Integra Lifesciences Corp. · Class II
- CRW® — Integra Lifesciences Corp. · Class II
- CRW® — Integra Lifesciences Corp. · Class II
- CRW® — Integra Lifesciences Corp. · Class II
- CRW® — Integra Lifesciences Corp. · Class II
- Integra® — Integra Lifesciences Corp. · Class II
- Headpins — Brainlab SE · Class II
Cleared under the same submission
K180586 also covers:
- Head Frame - Post Assembly Set — Varian Medical Systems, Inc
- Head Frame Cranial Screws - Long and Short — Varian Medical Systems, Inc
- Head Frame Kit — Varian Medical Systems, Inc
- VARIAN HEAD FRAME — Varian Medical Systems, Inc
- VARIAN HEAD FRAME PACKAGE — Varian Medical Systems, Inc
- Varian POST ASSY, STEREOTACTIC HEAD FRAME — Varian Medical Systems, Inc
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- Varian Medical Systems, Inc
Sources (2)
- FDA UDI c0e35e06-c127-45c4-861c-e6a125e92135 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026