Tenoglide Tendon Protector Sheet TG451

GUDID M269TG4511

TenoGlide Tendon Protector Sheet is an absorbable implant (device) that provides a non-constricting protective encasement for injured tendons. TenoGlide is comprised of a porous matrix of cross-linked bovine Type I collagen and glycosaminoglycan (GAG). TenoGlide Tendon Protector is designed to serve as an interface between the tendon and the surrounding tissues. TenoGlide Tendon Protector is an easy to handle, conformable, porous collagen-GAG sheet designed for easy placement under, around or over an injured tendon.

Integra Lifesciences Corporation

Tendon spacer

Primary Device ID	M269TG4511
NIH Device Record Key	23996b1d-27a0-41c9-8ecc-646ef0edc3c9
Commercial Distribution Status	In Commercial Distribution
Brand Name	Tenoglide Tendon Protector Sheet
Version Model Number	TG451
Catalog Number	TG451
Company DUNS	083171244
Company Name	Integra Lifesciences Corporation
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com

Device Dimensions

Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch
Width	10 Centimeter
Length	12.5 Centimeter
Width	4 Inch
Length	5 Inch

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Flat
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780032458 [Primary]
HIBCC	M269TG4511 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K053655

FDA Product Code

FTM	Mesh, surgical

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2020-07-16
Device Publish Date	2015-09-23

On-Brand Devices [Tenoglide Tendon Protector Sheet]

M269TG4511	TenoGlide Tendon Protector Sheet is an absorbable implant (device) that provides a non-constrict
M269TG2211	TenoGlide Tendon Protector Sheet is an absorbable implant (device) that provides a non-constrict