Duns Number:315028860
Catalog Number
20762059322
Brand Name
TUptake Calibrators
Version/Model Number
20762059322
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
K951595
Product Code
DLJ
Product Code Name
CALIBRATORS, DRUG SPECIFIC
Public Device Record Key
21d7632d-7ef1-450c-954d-7e0b83c61ec7
Public Version Date
October 12, 2020
Public Version Number
3
DI Record Publish Date
September 20, 2016
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 | 289 |
2 | A medical device with a moderate to high risk that requires special controls. | 760 |
3 | A medical device with high risk that requires premarket approval | 63 |
U | Unclassified | 4 |