Tensoplast®

Basic Information

• Brand Name: Tensoplast®
• Primary DI: 04042809005790
• Version / Model: 02167-00
• Company Name: BSN MEDICAL SAS
• Labeler DUNS: 397500849
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 16
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 1
• Public Version Date: 2022-12-16
• Public Version Status: New
• Public Device Record Key: ce45b808-f50b-4919-90d7-e38c7ea36fc3

Device Description

TENSOPLAST TAPE 7.5CMX4.5M STRETCHED TAN 16 USA

Device Characteristics

• Single Use: No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGX	Tape and bandage, adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59015	Pressure bandage, Hevea-latex, single-use	A strip or roll made of fabric with Hevea natural rubber latex (NRL) intended to be applied to and compress a local area of the body for various preventative/therapeutic applications (e.g., to stop bleeding, prevent oedema, provide support for varicose veins). The latex component is intended to create a bandage that clings to itself more than to skin so that compression can be maintained over longer periods. It is intended for use in the home or healthcare facility. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	04042809005776	GS1
Primary	04042809005790	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	7.5	Centimeter
Length	450	Centimeter