Device
Gauze Pads (Sterile) 2"
Manufacturer
VIVE HEALTH LLC
Model: RHB2081XS DI: 00810178887620 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: No OTC: Yes
First Published: 2026-04-27 Current Version: 2026-05-05
Description
Gauze Pads (Sterile) 2"
Sterilization
Method Types - Sterilization Method: Radiation Sterilization
Device Sterile: Yes
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 2818a06a-5c5c-4222-bd25-783f6f885290
Distribution Status: In Commercial Distribution
DUNS Number: 047025993
Device Count: 1
DM Exempt: Yes
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: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00810178887620
Type: Primary
Issuing Agency: GS1
GMDN
Code: 48134
Name: Woven gauze pad, non-antimicrobial
Definition:
A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to: clean, cover, or pack wounds or abrasions and absorb their exudates; absorb body-surface exudates; or apply topical medications. This is a single-use device.
FDA Product Codes
NAB
Gauze / Sponge,Nonresorbable For External Use