Duns Number:069472800
Device Description: UNIFUZE 20cc 1-Level Block (1 block/box), 6.25 x 2 x 0.8cm thickness
Catalog Number
-
Brand Name
Zavation
Version/Model Number
801-0020
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
K052812
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
b735e67c-3b74-4c3e-aa15-1b97c8e7ea38
Public Version Date
February 19, 2019
Public Version Number
1
DI Record Publish Date
January 19, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 375 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7471 |
| U | Unclassified | 22 |