Duns Number:056867526
Device Description: Holding Pipette
Catalog Number
K-HPIP-3330
Brand Name
Cook
Version/Model Number
G32810
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
26a3d42f-805c-48aa-aebd-f2a5eb306c41
Public Version Date
June 14, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10827002328102
Quantity per Package
10
Contains DI Package
00827002328105
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 |