Duns Number:783328149
Device Description: DELA-ROSA PLIER #858
Catalog Number
-
Brand Name
J&J Instruments
Version/Model Number
09-858
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JEX
Product Code Name
Plier, Orthodontic
Public Device Record Key
1948ff96-1857-45d6-a595-edf2ff7c6508
Public Version Date
October 25, 2019
Public Version Number
1
DI Record Publish Date
October 17, 2019
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 | 840 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |