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