Duns Number:080031617
Device Description: Standard burr, disposable
Catalog Number
R-10025
Brand Name
Curved Standard Ball Burr XL 5.0 mm
Version/Model Number
R-10025
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
Yes
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
K162770,K162770
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
fea19ed7-04e4-49e8-8278-9a282a2af1e8
Public Version Date
June 24, 2022
Public Version Number
1
DI Record Publish Date
June 16, 2022
Package DI Number
10859273007257
Quantity per Package
4
Contains DI Package
00859273007250
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 12 |