Duns Number:187502109
Device Description: 5MM BIOZIP W/O NEEDLES, 2 STRANDS #2 FORCE FIBER
Catalog Number
3910-200-025
Brand Name
Biozip
Version/Model Number
3910-200-025
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 07, 2018
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
K041305,K041305
Product Code
MAI
Product Code Name
FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Public Device Record Key
8762efb0-220c-4280-a802-19bb7c8da121
Public Version Date
March 21, 2019
Public Version Number
7
DI Record Publish Date
September 09, 2015
Package DI Number
37613154019862
Quantity per Package
5
Contains DI Package
07613154019861
Package Discontinue Date
December 07, 2018
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 |