Duns Number:078550672
Device Description: DOSELOGIX TC5-R-WHITE 5ML ROUND APPLICATOR
Catalog Number
755406
Brand Name
Doselogix
Version/Model Number
TC5-R-WHITE
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
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
3b359d69-4677-42eb-a02a-8cb1734d0864
Public Version Date
September 23, 2022
Public Version Number
1
DI Record Publish Date
September 15, 2022
Package DI Number
10813360022646
Quantity per Package
25
Contains DI Package
00813360022649
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 132 |