Duns Number:129278169
Catalog Number
SSI002297
Brand Name
JuggerKnot Soft Anchor
Version/Model Number
SSI002297
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
-
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
K110145
Product Code
MBI
Product Code Name
Fastener, Fixation, Nondegradable, Soft Tissue
Public Device Record Key
2696deb7-58eb-4c82-ac40-66b3c7f589b9
Public Version Date
April 06, 2020
Public Version Number
5
DI Record Publish Date
February 16, 2017
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 | 11962 |
2 | A medical device with a moderate to high risk that requires special controls. | 28376 |
3 | A medical device with high risk that requires premarket approval | 36 |
U | Unclassified | 4 |