DynaSafety Gauze Roll Bandage, Sterile, 4"

Basic Information

• Brand Name: DynaSafety Gauze Roll Bandage, Sterile, 4"
• Primary DI: 00840117332430
• Version / Model: 3194UB-1
• Company Name: Dynarex Corporation
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-14
• Public Version: 2
• Public Version Date: 2024-10-09
• Public Version Status: Update
• Public Device Record Key: f11a7385-5549-4806-8bc7-a78fe35501b6

Device Description

Offset

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: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FQM	Bandage, Elastic	General Hospital	880.5075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58805	Absorbent wound compression pad	A rolled strip of fabric material (e.g., non-woven polyester) intended to be applied around a wound (e.g., venous stasis ulcer of the leg) as a supplemental padded layer for a pressure bandage, primarily to help evenly distribute pressure and absorb exudates during the compression treatment of the wound. It is intended for use in the home or a clinical setting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840117332430	GS1
Package	00840117332423	GS1	Case	100	In Commercial Distribution