Duns Number:536139413
Device Description: Assisted Reproduction Microtools (Pipettes)
Catalog Number
7-72-1200/20
Brand Name
EZ-Strip
Version/Model Number
200 micron tip id
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
K991261,K991261
Product Code
MQH
Product Code Name
MICROTOOLS, ASSISTED REPRODUCTION (PIPETTES)
Public Device Record Key
72e3f68c-e077-4db0-a7b2-b35b189a9ce2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 17, 2016
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. | 68 |