AccessGUDID - DEVICE: HeadFrame Kit w/20 Short + 20 Long Head Screws (00858086006306)

GUDID

Device Identifier (DI) Information

Brand Name: HeadFrame Kit w/20 Short + 20 Long Head Screws
Version or Model: P1006805005
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VARIAN MEDICAL SYSTEMS, INC.

Primary DI Number: 00858086006306
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009120817 *Terms of Use

Device Description: Contains one 10858086006280 Cranial Screws, Case of 10 Boxes of 2 Short + 2 Long and one 00858086006252 Headframe Kit

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35361	Stereotactic radiosurgical invasive head frame	A device intended to be affixed to a patient's skull to enable precise localization of an area within the brain targeted for radiosurgical procedures (e.g., radiation treatment of a brain tumour). It is typically an assembly that includes a head ring or a head frame that is attached to the patient's head with fixation screws partially-embedded into the skull, an arc mechanism for setting target coordinates, and localizer frames and adaptors for precision placement to the simulator and imaging system [e.g., computed tomography (CT), magnetic resonance imaging (MRI), linear accelerator]. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, linear, medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180586	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d1db0441-c1c9-4a5d-92a4-ca80a2bb14c8
Public Version Date: January 25, 2021
Public Version Number: 1
DI Record Publish Date: January 16, 2021