Duns Number:305424269
Device Description: SAGE Vitrification Warming Kit. ART-8030-A: 1x4 ml 1.0M Surose Warming Solution, ART-8030- SAGE Vitrification Warming Kit. ART-8030-A: 1x4 ml 1.0M Surose Warming Solution, ART-8030-B: 1x2 ml 0.5M Sucrose Warming Solution, ART-8030-C: 1x6 ml MOPS Solution.
Catalog Number
-
Brand Name
Vitrification Warming Kit
Version/Model Number
ART-8030
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MQL
Product Code Name
Media, Reproductive
Public Device Record Key
c6e91cb0-2552-442a-90a6-7d752311f911
Public Version Date
September 25, 2018
Public Version Number
3
DI Record Publish Date
March 28, 2017
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. | 93 |