Duns Number:305424269
Device Description: SAGE 1-Step GM-CSF with SPS. 3 ml.
Catalog Number
-
Brand Name
SAGE 1-Step
Version/Model Number
77020003D
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
-
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
K172197
Product Code
MQL
Product Code Name
Media, Reproductive
Public Device Record Key
e3aa6120-f9df-48fd-a70b-dbac4e53f73a
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 27, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 93 |