FDA.reportPublic FDA data

Tenoglide Tendon Protector Sheet

Primary DI
M269TG4511
Brand
Tenoglide Tendon Protector Sheet
Company
Integra Lifesciences Corporation
Model
TG451
Catalog number
TG451
Device description
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.
Published
2015-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTMMesh, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053655000TENDON WRAP TENDON PROTECTORIntegra LifeSciences Corporation2006-02-03FTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780032458PrimaryGS10
M269TG4511SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178003245810381780032458

GMDN Terms#

Term, Definition table
TermDefinition
Tendon spacerAn implantable device intended to be used to physically isolate a tendon so that it can function without adhering to adjacent tissue.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Inch
Length12.5Centimeter
Width4Inch
Width10Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00Store Flat

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
083171244
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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