Duns Number:783328149
Device Description: EXTRACTING FCP #210
Catalog Number
-
Brand Name
J&J Instruments
Version/Model Number
06-210
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
EMG
Product Code Name
Forceps, Tooth Extractor, Surgical
Public Device Record Key
fc1e3536-6564-47dc-80a0-513d20992d78
Public Version Date
October 14, 2019
Public Version Number
1
DI Record Publish Date
October 04, 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 |