Duns Number:482661753
Device Description: TWISTR Outside-In ACL Disposables Kit Kit Contains: TWISTR Outside-In Suture Passing Fork, TWISTR Outside-In ACL Disposables Kit Kit Contains: TWISTR Outside-In Suture Passing Fork, 1.1mm x 15 Inches (38 cm) Nitinol Guidewire, 14 Inches Drill Tip Passing Pin (2.4mm x 35 cm), Malleable Graft Retractor, Marking Pen, Ruler (0-15cm Plus or Minus 0.5mm)
Catalog Number
232301
Brand Name
TWISTR
Version/Model Number
232301
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KDD
Product Code Name
Kit, surgical instrument, disposable
Public Device Record Key
c8717684-2a2e-4e51-9170-64b216f4001f
Public Version Date
August 30, 2021
Public Version Number
5
DI Record Publish Date
December 15, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |