CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 00885380027874
• Version / Model: S1042
• Catalog Number: S1042
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• 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: 60c4a9c2-4190-4f1d-9607-9eed93b9b8a8

Device Description

SKIN CLOSURE STRIP STERILE FILAMENT REINFORCED CURL-RESISTANT BREATHABLE 0.25IN X 1.5IN

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	20885380027878	GS1	BOX	50	In Commercial Distribution
Primary	00885380027874	GS1
Package	50885380027879	GS1	CASE	4	In Commercial Distribution
Unit of Use	10885380027871	GS1

Premarket Submissions

Submission Number	Supplement Number
K874813	000