Tenoglide®

Basic Information

• Brand Name: Tenoglide®
• Primary DI: 10381780032441
• Version / Model: TG221
• Catalog Number: TG221
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-23
• Public Version: 7
• Public Version Date: 2023-05-16
• Public Version Status: Update
• Public Device Record Key: bbe8c903-6276-4cf4-b80e-e0a2e76c84e2

Device Description

TenoGlide tendon protector sheet 2 in x 2 in (5cm x 5cm)

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: No
• 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
FTM	Mesh, surgical	General, Plastic Surgery	878.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35671	Tendon spacer	An implantable device intended to be used to physically isolate a tendon so that it can function without adhering to adjacent tissue.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M269TG2211	HIBCC
Primary	10381780032441	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K053655	000

Device Sizes

Type	Value	Unit	Text
Length	5	Centimeter
Width	2	Inch
Length	2	Inch
Width	5	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store Flat
• Type: Handling Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius