Duns Number:785335381
Device Description: Combo V24T centrifuge, digital, brushless, 12pl Test-tube rotor & 24pl Crit rotor, 110/220 Combo V24T centrifuge, digital, brushless, 12pl Test-tube rotor & 24pl Crit rotor, 110/220v auto
Catalog Number
CMC-1224-77T3
Brand Name
LW Scientific, Inc.
Version/Model Number
CMC-1224-77T3
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
GKG
Product Code Name
Centrifuge, Hematocrit
Public Device Record Key
b4e3e478-e2e6-42db-a82c-a7bd582b4a4f
Public Version Date
September 19, 2022
Public Version Number
1
DI Record Publish Date
September 09, 2022
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 | 94 |
2 | A medical device with a moderate to high risk that requires special controls. | 28 |