Duns Number:187502109
Device Description: 5MM BIOZIP WITH ¿ CIRCLE TAPER NEEDLES, 2 STRANDS #2 BRAIDED POLYESTER
Catalog Number
3910-200-020
Brand Name
Biozip
Version/Model Number
3910-200-020
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 09, 2017
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
K023192,K023192
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
e6fe42fc-2414-4a01-b6a8-af29ae878f7d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 09, 2015
Package DI Number
34546540392467
Quantity per Package
5
Contains DI Package
04546540392466
Package Discontinue Date
March 09, 2017
Package Status
Not 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 |