Omnifix Elastic 10cm x 2m P1 C64

Basic Information

• Brand Name: Omnifix Elastic 10cm x 2m P1 C64
• Primary DI: 04049500967754
• Version / Model: 900601 Omnifix Elastic 10cm x 2m P1 C64
• Company Name: PAUL HARTMANN AG
• Labeler DUNS: 315768788
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-01
• Public Version: 3
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: 99d507bc-f407-49d8-aad6-0c56293832f2

Device Description

Omnifix Elastic 10cm x 2m P1 C64

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
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16866	Dressing-fixation skin adhesive tape, non-silicone	A long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04052199277301	GS1		64	In Commercial Distribution
Primary	04049500967754	GS1