AccessGUDID - DEVICE: Individual (I-Skin) Calf Pads- Set (07540147002497)

GUDID

Device Identifier (DI) Information

Brand Name: Individual (I-Skin) Calf Pads- Set
Version or Model: D-0101-0157-MCP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCP
Company Name: Motion Concepts Inc

Primary DI Number: 07540147002497
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 259777209 *Terms of Use

Device Description: Individual (moulded i-skin) Calf Pads (Set) for use with Motion Concepts CM Legrests. One-size only. Mounting hardware included.

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: 650e5f36-beb2-4515-a71d-ebd9eb6babc8
Public Version Date: June 22, 2023
Public Version Number: 2
DI Record Publish Date: December 08, 2022