Duns Number:123853058
Device Description: Porcine Xenograft Particulate in Syringe, Particle Size 0.25 mm - 1.0 mm, Sterile, Content Porcine Xenograft Particulate in Syringe, Particle Size 0.25 mm - 1.0 mm, Sterile, Contents: 1.0 cc
Catalog Number
-
Brand Name
ZCORE
Version/Model Number
ZY100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 08, 2017
Issuing Agency
In HIBCC
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
-
Product Code
NPM
Product Code Name
Bone Grafting Material, Animal Source
Public Device Record Key
d7c7ced9-6791-4f8a-a403-05f75d9990b0
Public Version Date
December 10, 2018
Public Version Number
3
DI Record Publish Date
April 29, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |