Duns Number:693293734
Device Description: Assisted Reproduction Manipulator
Catalog Number
-
Brand Name
MM-94VM
Version/Model Number
MM-94VM Motor-Drive Manipulator
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
-
Product Code
MQJ
Product Code Name
Micromanipulators And Microinjectors, Assisted Reproduction
Public Device Record Key
68aee7e6-ac60-4505-8b66-1498ad55fc7c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 01, 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. | 30 |