AccessGUDID - DEVICE: Tenoglide® (10381780032458)

GUDID

Device Identifier (DI) Information

Brand Name: Tenoglide®
Version or Model: TG451
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TG451
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780032458
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: TenoGlide tendon protector sheet 4 in x 5 in (10cm x 12.5cm)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FTM	Mesh, surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K053655	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store Flat
Handling Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 10 Centimeter
Length: 12.5 Centimeter
Width: 4 Inch
Length: 5 Inch

Device Record Status

Public Device Record Key: 23996b1d-27a0-41c9-8ecc-646ef0edc3c9
Public Version Date: May 16, 2023
Public Version Number: 7
DI Record Publish Date: September 23, 2015