Duns Number:187502109
Device Description: 5.5MM PEEK ZIP SUTURE ANCHOR WITH ¿ CIRCLE TAPER NEEDLES, #2 FORCE FIBER
Catalog Number
3910-200-030
Brand Name
PEEK Zip
Version/Model Number
3910-200-030
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
K070758,K070758
Product Code
MBI
Product Code Name
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Public Device Record Key
82075a66-d8a4-4b6c-8a80-f1edca025cab
Public Version Date
March 21, 2019
Public Version Number
5
DI Record Publish Date
September 04, 2015
Package DI Number
37613154644521
Quantity per Package
5
Contains DI Package
07613154644520
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 |