Duns Number:064783913
Device Description: "Protects bur from being damaged during ultrasonic cleaning and sterilizationFits latch, f "Protects bur from being damaged during ultrasonic cleaning and sterilizationFits latch, friction grip and HP bursAdjustable height for multiple length bursDrain holes on the bottom of the bur guard help prevent rusting on the bursOne short bur adapter comes with one bur guard which enables long and short burs to be used in the same bur guardDimensions: 4-7/8"" x 7/16"" x 1-1/2""Autoclavable up to 136°C/275°FWasher-disinfect"
Catalog Number
-
Brand Name
Steri-Bur Guard 22-Hole Green
Version/Model Number
50Z410D-MANI
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
FSM
Product Code Name
Tray, Surgical, Instrument
Public Device Record Key
0c58b517-9168-4769-b727-85cf19762a6d
Public Version Date
October 13, 2022
Public Version Number
1
DI Record Publish Date
October 05, 2022
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 | 399 |