Duns Number:106793995
Device Description: Pipette, DiamondAPEX, Fully Autoclavable Adjustable Volume, 500 - 5000uL (1-5mL), Green
Catalog Number
-
Brand Name
Globe Scientific
Version/Model Number
3351-5000
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JRC
Product Code Name
Micro Pipette
Public Device Record Key
8951b9d4-8a1f-49b6-85d6-f8f8acc822ad
Public Version Date
September 02, 2020
Public Version Number
1
DI Record Publish Date
August 25, 2020
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 184 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |