Shur Strip®

Basic Information

• Brand Name: Shur Strip®
• Primary DI: 00809958000205
• Version / Model: 71153
• Catalog Number: DKC71153
• Company Name: Derma Sciences Canada Inc
• Labeler DUNS: 200564891
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1100
• Record Status: Published
• Publish Date: 2018-10-23
• Public Version: 2
• Public Version Date: 2022-11-07
• Public Version Status: Update
• Public Device Record Key: 55db3b51-6329-43ce-87bc-4c0379dc4789

Device Description

Shur Strip Wound Closure Strips Non-Sterile (Bulk)

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
Primary	00809958000205	GS1
Unit of Use	00809958000595	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1/2 in X 4 in
Device Size Text, specify			6 mm X 100 mm

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 80 Degrees Fahrenheit