H&H Flat Compressed Gauze

Basic Information

• Brand Name: H&H Flat Compressed Gauze
• Primary DI: 00857048006521
• Version / Model: 1
• Catalog Number: HHPF
• Company Name: H&H MEDICAL CORPORATION
• Labeler DUNS: 072656713
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-31
• Public Version: 2
• Public Version Date: 2022-02-21
• Public Version Status: Update
• Public Device Record Key: 0eced74a-c0db-4f27-a7c1-334bad653882

Device Description

H&H Compressed Gauze, z-folded flat containing a 4.5" x 4 yds (stretched) roll of crinkle fluff cotton gauze for use in wound management.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	878.4014	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47011	First aid absorbent pad/bandage	A wound cover intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding, and introduce medications placed on the pad. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10857048006528	GS1	Case	180	In Commercial Distribution
Primary	00857048006521	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]