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Head Frame Kit

FDA UDI

Class II (US FDA UDI)

by Varian Medical Systems, Inc

Identity

Trade Name
Head Frame Kit FDA UDI
Generic Name
Stereotactic radiosurgical invasive head frame FDA UDI
Model / Reference
P1006823004 FDA UDI

Identifiers

Primary DI / UDI-DI
00858086006252 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Stereotactic radiosurgical invasive head frame

Head Frame Kit by Varian Medical Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stereotactic radiosurgical invasive head frame.

Cleared under the same submission

K180586 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Varian Medical Systems, Inc

Sources (1)

  • FDA UDI bc586508-67d1-483e-9dc3-a1b467e6da44 33 fields · synced May 30, 2026