Duns Number:027532357
Device Description: IRIS SCISSORS CURVED 4.5" ECON
Catalog Number
-
Brand Name
Burkhart Dental Supply
Version/Model Number
72721014
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
EGN
Product Code Name
Scissors, Surgical Tissue, Dental
Public Device Record Key
366918a8-9634-4373-ac2e-29d55ef47fbc
Public Version Date
August 10, 2020
Public Version Number
1
DI Record Publish Date
August 01, 2020
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 | 214 |
2 | A medical device with a moderate to high risk that requires special controls. | 43 |