Duns Number:187502109
Device Description: NANOTACK SUTURE ANCHOR 1.4MM WITH INSERTER
Catalog Number
CAT01386
Brand Name
NanoTack
Version/Model Number
CAT01386
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 07, 2018
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
K131769
Product Code
MBI
Product Code Name
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Public Device Record Key
8e35e68c-c42f-4aa1-ae74-fa7c31cb4802
Public Version Date
March 21, 2019
Public Version Number
7
DI Record Publish Date
September 04, 2015
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 | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |