N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00614138113404
• Version / Model: 2149-S4
• Catalog Number: 2149-S4
• Company Name: TETRA MEDICAL SUPPLY CORP.
• Labeler DUNS: 047580212
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 96
• Record Status: Published
• Publish Date: 2022-08-08
• Public Version: 2
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: 75db3d46-52a5-4deb-baa1-53af09c0c21a

Device Description

4IN STERILE STRETCH GAUZE 96/CS

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: 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
48127	Woven gauze roll/sheet	A device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, and 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	00614138113404	GS1
Unit of Use	20614138113408	GS1

Customer Contacts

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