QuickGraft

Basic Information

• Brand Name: QuickGraft
• Primary DI: W41844300PSTT165
• Version / Model: 430PST
• Catalog Number: 430PST
• Company Name: Musculoskeletal Transplant Foundation, Inc.
• Labeler DUNS: 187560545
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-25
• Public Version: 1
• Public Version Date: 2019-07-03
• Public Version Status: New
• Public Device Record Key: bd609b64-3d72-4cf7-b792-622a14d778c0

Device Description

QuickGraft Pre-Sutured Tendon

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: Yes
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	878.5000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	W41844300PSTT165	ICCBBA

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K181633	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -90 – -40 Degrees Celsius