Duns Number:529124298
Device Description: 1ul, Flexible, Blue
Catalog Number
41121
Brand Name
Inoculating Loop
Version/Model Number
1ul, Flexible, 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
21094e53-8059-4539-ac0e-723c0c59fd8d
Public Version Date
September 05, 2022
Public Version Number
2
DI Record Publish Date
August 23, 2022
Package DI Number
16973267011212
Quantity per Package
6
Contains DI Package
06973267011215
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 |