Duns Number:071595540
Device Description: TruShot™ with Y-Knot® Shallow All-Suture Anchor (1.7 mm) with one #2-0 (3 metric) Hi-Fi® S TruShot™ with Y-Knot® Shallow All-Suture Anchor (1.7 mm) with one #2-0 (3 metric) Hi-Fi® Suture with Needles
Catalog Number
YSTN20
Brand Name
TruShot
Version/Model Number
YSTN20
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 19, 2020
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K182439
Product Code
MBI
Product Code Name
Fastener, fixation, nondegradable, soft tissue
Public Device Record Key
465f6478-bf28-4433-a165-4e039ce280db
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
July 17, 2019
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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |