QuickGraft
| Catalog Number: | 430PST |
|---|---|
| Company Name: | Musculoskeletal Transplant Foundation, Inc. |
| Device Combination Product: | N/A |
| Device Commercial Dsitribution End Date: | N/A |
| Device Commercial Dsitribution Status: | In Commercial Distribution |
| Device Count: | 1 |
| Device Description: | QuickGraft Pre-Sutured Tendon |
| Device hctp: | true |
| Device kit: | N/A |
| Device Publish Date: | 2019-06-25 |
| Device Record Status: | Published |
| Direct Market Exempt: | N/A |
| Has Donation ID number? | true |
| DUNS Number: | 187560545 |
| Has Expiration Date? | true |
| Is Labelled as NRL: | N/A |
| Is Labelled As No NRL: | true |
| Has Lot Batch Number: | N/A |
| Has Manufacutring Date: | N/A |
| MRI Safety Status: | Labeling does not contain MRI Safety Information |
| Is OTC? | N/A |
| Is Devic Premarket Exempt: | N/A |
| Public Device Record Key: | bd609b64-3d72-4cf7-b792-622a14d778c0 |
| Public Version Date: | 2019-07-03 |
| Public Version Number: | 1 |
| Public Version Status: | New |
| Is Rx? | true |
| Has Serial Number? | true |
| Is Single Use: | true |
| Version Model Number: | 430PST |
| Adress: | Phone:800-433-6576 Extension: Email: RA_Licenses@mtf.org |
Storage Condition
Storage Handling Type
Storage Handling High
Storage Handling Low
Storage Handling Special Condition
Storage Environment Temperature
GMDN Terms
GMDN Name
GMDN Term Definition
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.
Identifiers
Device ID
Device ID Type
Issuing Agency
Contains DI No
Pkg Qty
Pkg Discontinue dt
Pkg Status
Pkg Type
W41844300PSTT165
Primary
ICCBBA
Sterilization
Is Device Sterile
Is Steriliztion Prior Use
Sterilization Method
false
false
Product Codes
Product Code
Product Code Name
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
Pre Market Submisison
Submission Number
Supplement Number
K181633
000