Duns Number:117970217
Catalog Number
-
Brand Name
30mL DROPPER BOTTLE
Version/Model Number
AC211634-12
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"
Yes
For Single-Use
Yes
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
KYX
Product Code Name
Dispenser, Liquid Medication
Public Device Record Key
dffe7cb6-1c56-47ae-9171-d9f4c8800452
Public Version Date
August 26, 2022
Public Version Number
1
DI Record Publish Date
August 18, 2022
Package DI Number
10810080611280
Quantity per Package
12
Contains DI Package
00810080611283
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 | 103 |
2 | A medical device with a moderate to high risk that requires special controls. | 46 |