Duns Number:316403245
Device Description: Centrifuge Bucket / Tube Holder A device intended to compensate for and enable the use of Centrifuge Bucket / Tube Holder A device intended to compensate for and enable the use of different size test tubes and bottles in a centrifuge rotor bucket or centrifuge tube holder. This is a reusable device.
Catalog Number
1660
Brand Name
Bucket
Version/Model Number
1660
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GKG
Product Code Name
Centrifuge, Hematocrit
Public Device Record Key
e891cd0f-5169-4424-a93a-d52bc26e9d37
Public Version Date
September 13, 2021
Public Version Number
1
DI Record Publish Date
September 03, 2021
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 | 201 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |