Duns Number:315019588
Device Description: Assisted Reproduction Micromanipulator
Catalog Number
5191000023
Brand Name
TransferMan® 4m
Version/Model Number
5191000023
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 09, 2018
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
-
Product Code
MQJ
Product Code Name
Micromanipulators And Microinjectors, Assisted Reproduction
Public Device Record Key
4381d937-8537-4356-8cd6-b3e9a3c291ec
Public Version Date
November 14, 2018
Public Version Number
4
DI Record Publish Date
February 11, 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. | 4 |