Duns Number:482884061
Device Description: Paste-Fillers, standard, 171, 29 mm, # 30, handle GM
Catalog Number
02.171.29.030.GM
Brand Name
LENTULO
Version/Model Number
02.171.29.030.GM
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EIY
Product Code Name
Instrument, Filling, Plastic, Dental
Public Device Record Key
e8b630bc-0e10-4820-a843-780e585abbb6
Public Version Date
August 22, 2022
Public Version Number
1
DI Record Publish Date
August 14, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 200 |