Duns Number:187502109
Device Description: ICONIX 2 TT WITH INTELLIBRAID TECHNOLOGY, 2.3MM ANCHOR WITH 2 STRANDS 2.0MM XBRAID TT
Catalog Number
3910-500-322
Brand Name
ICONIX
Version/Model Number
3910500322
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
K133671,K133671
Product Code
MBI
Product Code Name
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Public Device Record Key
35730583-9cfe-42d0-ae33-0a9f729bc018
Public Version Date
March 21, 2019
Public Version Number
5
DI Record Publish Date
September 14, 2015
Package DI Number
37613327176934
Quantity per Package
5
Contains DI Package
07613327176933
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| 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 |