AccessGUDID - DEVICE: Tenoglide® (10381780032441)

GUDID

Device Identifier (DI) Information

Brand Name: Tenoglide®
Version or Model: TG221
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TG221
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780032441
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 2 in x 2 in (5cm x 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
Length: 5 Centimeter
Width: 2 Inch
Length: 2 Inch
Width: 5 Centimeter

Device Record Status

Public Device Record Key: bbe8c903-6276-4cf4-b80e-e0a2e76c84e2
Public Version Date: May 16, 2023
Public Version Number: 7
DI Record Publish Date: September 23, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
HIBCC	M269TG2211

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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