Duns Number:544504573
Catalog Number
-
Brand Name
VitaVitro
Version/Model Number
ZG-1.0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 05, 2026
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K180073,K180073,K180073
Product Code
MQK
Product Code Name
Labware, Assisted Reproduction
Public Device Record Key
a22b4866-3785-4590-aefe-ba250e179c32
Public Version Date
February 22, 2021
Public Version Number
4
DI Record Publish Date
December 05, 2018
Package DI Number
16971982050028
Quantity per Package
3
Contains DI Package
06971982050021
Package Discontinue Date
December 05, 2026
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 22 |