AccessGUDID - DEVICE: KNEE SEPARATOR (G0648317270046640)

GUDID

Device Identifier (DI) Information

Brand Name: KNEE SEPARATOR
Version or Model: 831727004664
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 831727004664
Company Name: Walgreen Health Solutions, LLC

Primary DI Number: G0648317270046640
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116685742 *Terms of Use

Device Description: KNEE SEPARATOR, Leg/Knee Cushion (One Size)

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?
41542	Leg/knee cushion	A soft pillow or pad intended to be placed under or between the leg(s)/knee(s) of a patient during the treatment/prevention of musculoskeletal and/or circulatory disorders. It is primarily intended for support when the patient is lying down, and may be used for one or more of the following: to reduce pressure on or between the legs, to improve postural alignment (e.g., of the spine or legs), to improve blood circulation in the lower extremities, and/or to prevent pressure sores/ulcers.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMP	Protector, Skin Pressure

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: 2a67688f-d82f-4e47-8a8e-cc797416c391
Public Version Date: December 19, 2022
Public Version Number: 1
DI Record Publish Date: December 09, 2022