Duns Number:187502109
Device Description: 3.5mm PEEK TWINLOOP FLEX ONE STRAND 2 FORCE FIBER
Catalog Number
3910-405-638
Brand Name
TwinLoop FLEX
Version/Model Number
3910-405-638
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
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
-
Product Code
MBI
Product Code Name
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Public Device Record Key
112c4338-4e2b-4d34-a30c-2fe40ef37725
Public Version Date
March 21, 2019
Public Version Number
4
DI Record Publish Date
August 26, 2015
Package DI Number
34546540678325
Quantity per Package
5
Contains DI Package
04546540678324
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 |