Duns Number:529124298
Device Description: 10ul, Rigid, Dark blue
Catalog Number
41211
Brand Name
Inoculating Loop
Version/Model Number
10ul, Rigid, Dark blue
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LIB
Product Code Name
Device, General Purpose, Microbiology, Diagnostic
Public Device Record Key
8d5a393c-85e5-450a-aa26-24799d9af81f
Public Version Date
September 05, 2022
Public Version Number
2
DI Record Publish Date
August 23, 2022
Package DI Number
16973267012110
Quantity per Package
6
Contains DI Package
06973267012113
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 4 |