ADHESIVE STRIPS

Basic Information

• Brand Name: ADHESIVE STRIPS
• Primary DI: 13700773727589
• Version / Model: S3.0500
• Company Name: FCI S A S FCI 20 22
• Labeler DUNS: 763408366
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-08
• Public Version: 1
• Public Version Date: 2022-03-16
• Public Version Status: New
• Public Device Record Key: b3aed787-74d7-49ef-8a8a-e8c7741adf51

Device Description

ADHESIVE STRIPS

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
MML	Weights, Eyelid, External	Ophthalmic	886.5700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34831	Hypoallergenic skin adhesive tape	A flexible band of fabric, plastic, paper, or other material, coated on one side with a pressure-sensitive adhesive, and designed with a lower potential for producing an allergic reaction (i.e., hypoallergenic), intended to non-invasively adhere to the skin surface to fix a dressing in place, or attach objects (e.g., catheter); it is not waterproof. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	13700773727589	GS1