Duns Number:783328149
Device Description: MOLT CURETTE #4
Catalog Number
02-294
Brand Name
J&J Instruments
Version/Model Number
02-294
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
EKE
Product Code Name
Curette, Operative
Public Device Record Key
ab4e8334-05c3-41c4-8799-f6d8b637a376
Public Version Date
November 16, 2018
Public Version Number
1
DI Record Publish Date
October 16, 2018
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 |