Duns Number:152161337
Device Description: GM501 Gradient 45% is a ready-to-use gradient system for semen preparation and can be used GM501 Gradient 45% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICSI procedures.
Catalog Number
-
Brand Name
GM501 Gradient 45%
Version/Model Number
4GM501GR-45-250
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)
Yes
FDA Premarket Submission
K053494
Product Code
MQL
Product Code Name
Media, Reproductive
Public Device Record Key
58831987-494a-41cd-aa6f-9ef8c9dc6a2d
Public Version Date
May 10, 2021
Public Version Number
1
DI Record Publish Date
April 30, 2021
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. | 53 |