AccessGUDID - DEVICE: Birkova (00724995213060)

GUDID

Device Identifier (DI) Information

Brand Name: Birkova
Version or Model: Table Pads
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PP5225
Company Name: STERIS CORPORATION

Primary DI Number: 00724995213060
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 036985604 *Terms of Use

Device Description: Head Positioner Donut, xLarge 10 inch outer diameter x 6 inch inner diameter x 2 inch height

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	Yes
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?
64413	Freestanding headrest, single-use	A device designed to be placed on a flat surface (e.g., operating/examination table, stretcher) to support and stabilize the head of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations; it is not attached to a parent device. The headrest is typically made of shock-absorbing materials (e.g., memory foam, gel) that cushion the head and is available in various sizes and shapes including head pad, head ring, and concave ergonomic holders with fingered lateral supports to position the head. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LWG	SURGICAL TABLE CUSHION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: 756b3909-1d86-47a3-852c-1545bdd3483c
Public Version Date: July 08, 2021
Public Version Number: 1
DI Record Publish Date: June 30, 2021