Duns Number:043833813
Device Description: Atomlab Wipe Test Counter
Catalog Number
086-331
Brand Name
Atomlab Wipe Test Counter
Version/Model Number
086-331
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
K090296
Product Code
KPT
Product Code Name
Calibrator, Dose, Radionuclide
Public Device Record Key
9f8491d0-f1fa-4d94-b713-d8f4cb546cfb
Public Version Date
February 24, 2020
Public Version Number
1
DI Record Publish Date
February 14, 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 | 193 |
2 | A medical device with a moderate to high risk that requires special controls. | 52 |