Duns Number:119193803
Device Description: Bur storage, sterilization, and retrieval easier and safer than ever. Unique design store Bur storage, sterilization, and retrieval easier and safer than ever. Unique design stores six burs horizontally and removal is as simple as pressing down on one end. Two models accommodate both FG and RA Burs and slide easily into small, flat sterilization pouches. Fully Sterilization at 375 degree F
Catalog Number
70-39730 PUR
Brand Name
BurSafe Bur Holder-Pure Purple
Version/Model Number
53C9060
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
FSM
Product Code Name
Tray, Surgical, Instrument
Public Device Record Key
bef573a9-fb24-44b2-be91-8ab6eefdb59d
Public Version Date
October 18, 2019
Public Version Number
1
DI Record Publish Date
October 10, 2019
Package DI Number
00723896006191
Quantity per Package
50
Contains DI Package
00723896006153
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 93 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |