Duns Number:013369913
Device Description: Jiffy Natural Composite Diamond Finishing & Polishing Kit
Catalog Number
6105
Brand Name
Jiffy Natural Composite
Version/Model Number
6105
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
EHM
Product Code Name
STRIP, POLISHING AGENT
Public Device Record Key
8a609da8-434b-4861-ab1d-82ce20aa3da8
Public Version Date
March 23, 2020
Public Version Number
4
DI Record Publish Date
June 07, 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 | 450 |
2 | A medical device with a moderate to high risk that requires special controls. | 631 |
U | Unclassified | 18 |