Identity
- Trade Name
- Head Frame Cranial Screws - Long and Short FDA UDI
- Generic Name
- Stereotactic radiosurgical invasive head frame FDA UDI
- Device Name
- Contains one 10858086006266 Cranial Screws, Long, Pouch of 2 and one 10858086006273 Cranial Screws, Short, Pouch of 2 FDA UDI
- Model / Reference
- P1006801006 FDA UDI
- Description
- Contains one 10858086006266 Cranial Screws, Long, Pouch of 2 and one 10858086006273 Cranial Screws, Short, Pouch of 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858086006283 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Stereotactic radiosurgical invasive head frame
Head Frame Cranial Screws - Long and Short by Varian Medical Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Stereotactic radiosurgical invasive head frame.
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- CRW® — Integra Lifesciences Corp. · Class II
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Cleared under the same submission
K180586 also covers:
- Head Frame - Post Assembly Set — Varian Medical Systems, Inc
- Head Frame Kit — Varian Medical Systems, Inc
- VARIAN HEAD FRAME — Varian Medical Systems, Inc
- VARIAN HEAD FRAME KIT — Varian Medical Systems, Inc
- VARIAN HEAD FRAME PACKAGE — Varian Medical Systems, Inc
- Varian POST ASSY, STEREOTACTIC HEAD FRAME — Varian Medical Systems, Inc
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
- Varian Medical Systems, Inc
Sources (1)
- FDA UDI 483dc247-ca44-403f-8774-b4349cd3c6aa 34 fields · synced May 30, 2026