Henry Schein

Basic Information

• Brand Name: Henry Schein
• Primary DI: H68210481941
• Version / Model: 1048194
• Catalog Number: 1048194
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2019-01-31
• Public Version: 1
• Public Version Date: 2019-03-04
• Public Version Status: New
• Public Device Record Key: 3de437a4-951f-438c-a5df-1d7650e74c04

Device Description

Sponge Premium Non-Sterile

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: Yes
• 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: No
• 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
48133	Woven gauze pad, non-sterile	A non-medicated, non-sterile 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 cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	H68210481941	HIBCC
Unit of Use	H68210481949	HIBCC