AccessGUDID - DEVICE: Headrest (00841439107843)

GUDID

Device Identifier (DI) Information

Brand Name: Headrest
Version or Model: MTTIMO
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MTTIMO
Company Name: MEDTEC, INC.

Primary DI Number: 00841439107843
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103977526 *Terms of Use

Device Description: (19.8 x 12.2 x 6.4cm) size A; (22.6 x 11.9 x 6.4cm) size B; (23.1 x 11.7 x 7.4cm) size C; (23.4 x 12.4 x 8.9cm) size D; (21.8 x 12.2 x 10.2cm) size E;(23.4 x 12.2 x 9.1cm) size F

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	Yes
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?
61132	Radiological headrest	A non-sterile device intended to facilitate adequate positioning and immobilization of the patient's head and neck for reproducible positioning during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, cushion, or preformed pad that is intended to directly contact the head, and which may be customizable for single-patient use. 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 [?]
K080072	000
K933227	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 4.7 Inch
Length: 8.9 Inch

Device Record Status

Public Device Record Key: 4ab7475e-3713-4a19-847d-f40221dbdd95
Public Version Date: December 22, 2020
Public Version Number: 5
DI Record Publish Date: August 02, 2017