H-E-B

Basic Information

• Brand Name: H-E-B
• Primary DI: 00041220832439
• Version / Model: 041220832439
• Company Name: H. E. BUTT GROCERY COMPANY
• Labeler DUNS: 007924756
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2020-07-27
• Public Version: 3
• Public Version Date: 2021-08-24
• Public Version Status: Update
• Public Device Record Key: f4ea7b1b-17cc-4004-8226-d88120f8e946
• Distribution End Date: 2020-12-17

Device Description

Gauze Pads, 4 IN x 4 IN (101 mm x 101 mm)

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
48131	Non-woven gauze pad	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. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20041220832433	GS1	case	36	Not in Commercial Distribution	2020-12-17
Primary	00041220832439	GS1
Unit of Use	60041220832431	GS1