Duns Number:071595540
Device Description: TruShot™ with Y-Knot® 1.3 mm All-Suture Anchor with one #2 (5 metric) Hi-Fi® Suture with N TruShot™ with Y-Knot® 1.3 mm All-Suture Anchor with one #2 (5 metric) Hi-Fi® Suture with Needles
Catalog Number
Y13TN
Brand Name
TruShot
Version/Model Number
Y13TN
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K182446,K182446
Product Code
MBI
Product Code Name
Fastener, fixation, nondegradable, soft tissue
Public Device Record Key
5db5cccc-0598-429b-9dae-25d503866f2b
Public Version Date
December 28, 2020
Public Version Number
1
DI Record Publish Date
December 19, 2020
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 |