AccessGUDID - DEVICE: Protekt Parts (05060488572920)

GUDID

Device Identifier (DI) Information

Brand Name: Protekt Parts
Version or Model: PP-WLE8GT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PP-WLE8GT
Company Name: PROACTIVE MEDICAL PRODUCTS, LLC

Primary DI Number: 05060488572920
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078582655 *Terms of Use

Device Description: Wheel Lock Extension 8 Inch w/ Tether and Cap(STDS801GT) (ea)

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?
31158	Wheelchair brakes	A device consisting of a lever(s), spring(s), tyre contact pads, or other mechanism used to slow down, stop, and/or hold a wheelchair in a stationary position. This GMDN code also includes the necessary installation package.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IML	ARMREST, 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
Height: 4 Inch
Length: 8 Inch
Width: 2 Inch

Device Record Status

Public Device Record Key: e1d12fba-9708-4a3b-84aa-ca5778f2c854
Public Version Date: November 28, 2022
Public Version Number: 1
DI Record Publish Date: November 18, 2022