AccessGUDID - DEVICE: FlexiGRAFT® (00889858157117)

GUDID

Device Identifier (DI) Information

Brand Name: FlexiGRAFT®
Version or Model: FTBDL095106
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FTBDL
Company Name: LIFENET HEALTH

Primary DI Number: 00889858157117
Issuing Agency: GS1
Commercial Distribution End Date: December 01, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 121828156 *Terms of Use

Device Description: Triple Bundle

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):	Yes

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60501	Tendon graft	A sterile tendon tissue, which may include a bone block, intended for transplantation that is harvested from a human donor. The tissue is intended to be used to replace or strengthen damaged tendon in any part of the human body. It may include non-tissue components (e.g. suture) to facilitate its implantation or function. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 106 Millimeter
Outer Diameter: 9.5 Millimeter

Device Record Status

Public Device Record Key: 4a1e47f1-4f75-484f-8ddf-e333e23da6f2
Public Version Date: December 17, 2021
Public Version Number: 4
DI Record Publish Date: September 24, 2015