AccessGUDID - DEVICE: Pro Advantage (M220P0725033)

GUDID

Device Identifier (DI) Information

Brand Name: Pro Advantage
Version or Model: P072503
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P072503
Company Name: NATIONAL DISTRIBUTION & CONTRACTING, INC.

Primary DI Number: M220P0725033
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009831413 *Terms of Use

Device Description: PA STOCKINETTE COTTON 3X25YD - (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:	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?
35374	Stockinette	A knitted, seamless, expandable tubing, typically made of cotton, that is open at both ends and intended to be used to hold bandages in place; to place uniform pressure on a leg, finger, arm, or other part of an extremity; to pad the area under a cast, splint or orthosis; or to cover a stump when a prosthesis is worn. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IPM	Cover, Limb

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: 0a4a8f4a-454d-44c9-841f-2bbe8ddd279b
Public Version Date: February 05, 2024
Public Version Number: 2
DI Record Publish Date: October 10, 2022