AccessGUDID - DEVICE: Head Frame Cranial Screws - Long and Short (00858086006283)

GUDID

Device Identifier (DI) Information

Brand Name: Head Frame Cranial Screws - Long and Short
Version or Model: P1006801006
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VARIAN MEDICAL SYSTEMS, INC.

Primary DI Number: 00858086006283
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009120817 *Terms of Use

Device Description: Contains one 10858086006266 Cranial Screws, Long, Pouch of 2 and one 10858086006273 Cranial Screws, Short, Pouch of 2

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: 483dc247-ca44-403f-8774-b4349cd3c6aa
Public Version Date: January 25, 2021
Public Version Number: 1
DI Record Publish Date: January 16, 2021