Device
ProCure Bordered Gauze Island Dressing 4"x 4" - 10ea/bg 10bg/pk 40pk/cs(400bg/cs)
Manufacturer
Twin Med, LLC
Model: PCHBG44N Catalog: PCHBG44N DI: 10840330702550 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: No OTC: Yes
First Published: 2026-04-28 Current Version: 2026-05-06
Description
ProCure Bordered Gauze Island Dressing 4"x 4" - 10ea/bg 10bg/pk 40pk/cs(400bg/cs)
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 84b21b48-08db-4923-96a8-fcb4b7b95603
Distribution Status: In Commercial Distribution
DUNS Number: 107071289
Device Count: 10
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: Yes
Identifiers
Item #1 - Pkg Type: Box
Item #1 - Device ID: 30840330702554
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 10
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 10840330702550
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 10840330702550
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
Item #3 - Pkg Type: Case
Item #3 - Device ID: 50840330702558
Item #3 - Pkg Status: In Commercial Distribution
Item #3 - Pkg Quantity: 40
Item #3 - Device ID Type: Package
Item #3 - Contains DINumber: 30840330702554
Item #3 - Device ID Issuing Agency: GS1
Item #4 - Device ID: 00840330702553
Item #4 - Device ID Type: Unit of Use
Item #4 - Device ID Issuing Agency: GS1
GMDN
Code: 44990
Name: Skin-cover adhesive strip, non-antimicrobial
Definition:
A small, narrow, flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive and possibly with an absorbent pad, typically intended to cover a superficial wound or fix a dressing to skin. It may be hypoallergenic and/or waterproof, however it does not include antimicrobial agents/properties. Commonly referred to as a sticking plaster, it is intended for use in the home or a clinical setting. This is a single-use device.
FDA Product Codes
NAC
Dressing, Wound, Hydrophilic
Device Sizes
Item #1 - Size - @attributes - Unit: Centimeter
Item #1 - Size - @attributes - Value: 10
Item #1 - Size Type: Length
Item #2 - Size - @attributes - Unit: Centimeter
Item #2 - Size - @attributes - Value: 10
Item #2 - Size Type: Width
Item #3 - Size Text: Pad is 5cm by 5cm
Item #3 - Size Type: Device Size Text, specify