Duns Number:013369913
Device Description: Jiffy RA Assorted Natural Universal 14mm Wheel 6 pack
Catalog Number
6082
Brand Name
Jiffy Natural Universal
Version/Model Number
6082
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
EJQ
Product Code Name
WHEEL, POLISHING AGENT
Public Device Record Key
aeeee40c-9f2a-40fa-a6ec-4e4992fd1212
Public Version Date
March 23, 2020
Public Version Number
4
DI Record Publish Date
October 26, 2017
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 |