FLEXOPLAST®

Basic Information

• Brand Name: FLEXOPLAST®
• Primary DI: 00809958000564
• Version / Model: 100-3
• Catalog Number: GL100-3
• Company Name: Derma Sciences Canada Inc
• Labeler DUNS: 200564891
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2018-10-23
• Public Version: 2
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: 519bab32-783e-49f8-b6fb-7b8a836a8ad9

Device Description

5 yards stretched, 3 inch width Elastic Woven Bandage

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FQM	BANDAGE, ELASTIC	General Hospital	880.5075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35374	Stockinette	A knitted, seamless, expandable tubing, typically made of cotton, that is open at both ends and intended to be used to hold bandages in place; to place uniform pressure on a leg, finger, arm, or other part of an extremity; to pad the area under a cast, splint or orthosis; or to cover a stump when a prosthesis is worn. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00809958000564	GS1
Unit of Use	00809958000892	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			No Relevant Sizes
Device Size Text, specify			3 in X 5 yds