BGEcare Sterile OR Towel

Basic Information

• Brand Name: BGEcare Sterile OR Towel
• Primary DI: 06972403300640
• Version / Model: OT051723010420S
• 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: 2021-03-08
• Public Version: 1
• Public Version Date: 2021-03-16
• Public Version Status: New
• Public Device Record Key: 12554eb1-0d31-4c8f-99bf-c164c8e01617

Device Description

BGEcare Sterile OR Towel 17"X23", Blue, 4 pieces/pack, 20 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: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRL	Fiber, Medical, Absorbent	General Hospital	880.5300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
14077	Surgical towel	A sterile cloth used in the operating room (OR) to absorb extraneous fluids. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	06972403300657	GS1	carton box	20	In Commercial Distribution
Primary	06972403300640	GS1