Device
ProCure Bordered Gauze Island Sterile 4"x8" 25ea/bx 20bx/cs
Manufacturer
Twin Med, LLC
Twin Med, LLC
Model: PCHBG48
Catalog: PCHBG48
DI: 10840330702512
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 Sterile 4"x8" 25ea/bx 20bx/cs
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
660cb4d1-7994-4bdc-9afe-93577640da54
Distribution Status:
In Commercial Distribution
DUNS Number:
107071289
Device Count:
1
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:
30840330702516
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
25
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10840330702512
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10840330702512
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Case
Item #3 - Device ID:
50840330702510
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
20
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
30840330702516
Item #3 - 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:
20
Item #2 - Size Type:
Width
Item #3 - Size Text:
Pad is 5cm by 15cm
Item #3 - Size Type:
Device Size Text, specify