Duns Number:056867526
Device Description: Flexipet Denuding Pipette
Catalog Number
K-FPIP-1140-10
Brand Name
Cook Flexipet
Version/Model Number
G46019
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
-
Product Code
MQH
Product Code Name
MICROTOOLS, ASSISTED REPRODUCTION (PIPETTES)
Public Device Record Key
20ef865f-8f57-4d96-9dcb-aaefb7dec2cd
Public Version Date
June 20, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10827002460192
Quantity per Package
10
Contains DI Package
00827002460195
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 11 |
2 | A medical device with a moderate to high risk that requires special controls. | 48 |