AccessGUDID - DEVICE: Positioning Cushion (00841439100899)

GUDID

Device Identifier (DI) Information

Brand Name: Positioning Cushion
Version or Model: 301008
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 301008
Company Name: MEDTEC, INC.

Primary DI Number: 00841439100899
Issuing Agency: GS1
Commercial Distribution End Date: March 20, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 103977526 *Terms of Use

Device Description: Reusable Non-Sterile Head Support

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
LNH	System, nuclear magnetic resonance imaging
IYE	Accelerator, linear, medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060737	000
K093738	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: 5.5 Inch
Length: 9.1 Inch

Device Record Status

Public Device Record Key: 58ad691e-f470-4c9b-b9d7-5f61e682e996
Public Version Date: March 20, 2019
Public Version Number: 6
DI Record Publish Date: August 02, 2017