AccessGUDID - DEVICE: QuickGraft (W41844300PSTT165)

GUDID

Device Identifier (DI) Information

Brand Name: QuickGraft
Version or Model: 430PST
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 430PST
Company Name: Musculoskeletal Transplant Foundation, Inc.

Primary DI Number: W41844300PSTT165
Issuing Agency: ICCBBA
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 187560545 *Terms of Use

Device Description: QuickGraft Pre-Sutured Tendon

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":	Yes
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 [?]
K181633	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -90 and -40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bd609b64-3d72-4cf7-b792-622a14d778c0
Public Version Date: July 03, 2019
Public Version Number: 1
DI Record Publish Date: June 25, 2019