Duns Number:838734093
Device Description: Zip® Implant - 20 mm (STERILE) [6 PK]
Catalog Number
81-3518
Brand Name
Bioplate@
Version/Model Number
81-3518
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 01, 2022
Issuing Agency
In HIBCC
MRI safety Status
MR Conditional
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
K070901,K070901
Product Code
GXN
Product Code Name
Plate, Cranioplasty, Preformed, Non-Alterable
Public Device Record Key
b4ae00cd-0370-4f32-bde1-c04f6226bce1
Public Version Date
February 23, 2022
Public Version Number
6
DI Record Publish Date
December 03, 2015
Package DI Number
M3848135181
Quantity per Package
6
Contains DI Package
M3848135180
Package Discontinue Date
February 01, 2022
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 198 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 506 |