Duns Number:316788397
Catalog Number
-
Brand Name
neodisher Mielclear
Version/Model Number
4029577140724
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2021
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FLG
Product Code Name
Cleaner, Ultrasonic, Medical Instrument
Public Device Record Key
859a0f10-e17e-48e1-8d45-57cb2a8a7a9f
Public Version Date
January 17, 2022
Public Version Number
2
DI Record Publish Date
August 16, 2020
Package DI Number
04029577140717
Quantity per Package
12
Contains DI Package
04029577140724
Package Discontinue Date
December 31, 2021
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 39 |