Omnifix silicone, 10cmx5m, P1

Basic Information

• Brand Name: Omnifix silicone, 10cmx5m, P1
• Primary DI: 04052199575940
• Version / Model: 900001 Omnifix silicone, 10cmx5m, P1
• Catalog Number: 900001
• Company Name: PAUL HARTMANN AG
• Labeler DUNS: 315768788
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-07
• Public Version: 4
• Public Version Date: 2025-04-17
• Public Version Status: Update
• Public Device Record Key: 244d631a-57b2-44b9-a0fb-7b4664486a74

Device Description

Omnifix silicone, 10cmx5m, P1

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: 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58749	Dressing-fixation skin adhesive tape, silicone	A long and narrow flexible band of plastic, fabric or other material, with an adhesive layer made of soft silicone, designed to cover a surface (e.g., small wound), fix a dressing, or attach objects/devices to the body. The silicone layer is intended to be less allergenic and to allow for easy removal with less trauma to skin and less adhesion to bodily hair than conventional pressure-sensitive adhesives. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04052199575957	GS1		12	In Commercial Distribution
Primary	04052199575940	GS1