634 - Certi-Gauze Roll - 2" x 6 yards - 2/Unit

Basic Information

• Brand Name: 634 - Certi-Gauze Roll - 2" x 6 yards - 2/Unit
• Primary DI: 00766588110240
• Version / Model: R211-024
• Catalog Number: R211-024
• Company Name: Certified Safety Manufacturing, Inc.
• Labeler DUNS: 788460483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-27
• Public Version: 2
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: 8b3b8d87-a9e5-42b6-ad69-4319db85ff1e

Device Description

634 - Certi-Gauze Roll - 2" x 6 yards - 2/Unit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• 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
EFQ	GAUZE/SPONGE, INTERNAL	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
63661	Non-woven gauze roll/sheet	A device in the form of a long length of stretchable, non-woven material (e.g., rayon/polyester), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00766588110240	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K945002	000