CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 00885380027881
• Version / Model: S1046
• Catalog Number: S1046
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-06-25
• Public Version: 1
• Public Version Date: 2019-07-03
• Public Version Status: New
• Public Device Record Key: a81e18c1-3932-4574-b7d4-d7bd5bb082d5

Device Description

SKIN CLOSURE STRIP STERILE FILAMENT REINFORCED CURL-RESISTANT BREATHABLE 0.25IN X 4IN

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
FPX	Strip, adhesive, closure, skin	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32207	Skin-closure adhesive strip	A small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885380027886	GS1	CASE	4	In Commercial Distribution
Package	20885380027885	GS1	BOX	50	In Commercial Distribution
Primary	00885380027881	GS1
Unit of Use	10885380027888	GS1

Premarket Submissions

Submission Number	Supplement Number
K874813	000