Duns Number:187502109
Device Description: 2.3MM ICONIX 3 ANCHOR W/INTELLIBRAID TECHNOLOGY 3 STRANDS #2 FORCE FIBER
Catalog Number
3910-500-532
Brand Name
ICONIX
Version/Model Number
3910-500-532
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
bc19bb00-8278-45e2-982a-310f33dfbdb7
Public Version Date
March 21, 2019
Public Version Number
5
DI Record Publish Date
August 26, 2015
Package DI Number
37613252450369
Quantity per Package
5
Contains DI Package
07613252450368
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 |