BGEcare Non-sterile Gauze Sponge

Basic Information

• Brand Name: BGEcare Non-sterile Gauze Sponge
• Primary DI: 06972403300534
• Version / Model: GS0104041220010NS
• Company Name: Xuchang Zhende Surgical Dressing Co., Ltd.
• Labeler DUNS: 528104096
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-11
• Public Version: 1
• Public Version Date: 2021-03-19
• Public Version Status: New
• Public Device Record Key: 72f3feb4-371e-4cca-aa10-58c46589b200

Device Description

BGEcare Non-sterile Gauze Sponge 4''X4'', 12-Ply, 200 pieces/pack,10 packs/carton box

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
Package	06972403300541	GS1	carton box	10	In Commercial Distribution
Primary	06972403300534	GS1