Model: 170-2010-0020
DI: 00041298994428
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-04
Current Version: 2026-05-12
Description
Sterile Gauze Pads – 5” x9” 20/bx
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
db05ce89-1bd5-406e-946d-a1c380cd98bf
Distribution Status:
In Commercial Distribution
DUNS Number:
062028220
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:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Master carton
Item #1 - Device ID:
10041298994425
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
24
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00041298994428
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00041298994428
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 48131
Name: Non-woven gauze pad
Definition:
A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum; in some cases, the device’s packaging may be used as a disposable tray. This is a single-use device.
FDA Product Codes
NAB
Gauze / Sponge,Nonresorbable For External Use