AccessGUDID - DEVICE: Knee Bolster Pads (07540147002183)

GUDID

Device Identifier (DI) Information

Brand Name: Knee Bolster Pads
Version or Model: D-0223-0227-KBP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KBP
Company Name: Motion Concepts Inc

Primary DI Number: 07540147002183
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 259777209 *Terms of Use

Device Description: Knee Bolster Pads are designed for use with the Modular Knee Bolster or optional Eccentric Knee Bolster on Motion Concepts Modular Power Standing Systems. Knee Bolster Pads are available in 6", 8" and 10" pad sizes.

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):	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?
65005	Wheelchair legrest pad	A contoured or padded device intended to be attached to wheelchair footrests so that it can provide a comfortable platform to support the calves of the legs (legrest).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNN	Components, Wheelchair

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: 8c6b7672-de07-4fb1-9246-1bd80a620879
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022