AccessGUDID - DEVICE: DONUT, POSTION, 7" FOAM BLUE (00842430105852)

GUDID

Device Identifier (DI) Information

Brand Name: DONUT, POSTION, 7" FOAM BLUE
Version or Model: 1922
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1922
Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.

Primary DI Number: 00842430105852
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 24
Labeler D-U-N-S® Number*: 084527241 *Terms of Use

Device Description: No description.

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:	Yes
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?
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
CCX	Support, Patient Position

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: 172f80fe-8133-4c85-80d8-01b574202fa6
Public Version Date: July 01, 2021
Public Version Number: 2
DI Record Publish Date: April 05, 2019