Duns Number:305424269
Device Description: SAGE Vitrification Kit. ART-8026 (in plastic cryo vials):2x2 ml ART-8026-A, Equilibration SAGE Vitrification Kit. ART-8026 (in plastic cryo vials):2x2 ml ART-8026-A, Equilibration Solution. 2x2 ml ART-8026-B, Vitrification Solution.
Catalog Number
-
Brand Name
SAGE Vitrification Kit
Version/Model Number
ART-8026
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
-
Product Code
MQL
Product Code Name
Media, Reproductive
Public Device Record Key
de3f0d36-00d7-4ead-b514-4f18cd5db09d
Public Version Date
September 25, 2018
Public Version Number
3
DI Record Publish Date
May 31, 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 |