Catalog Number

-

Brand Name

Guided Surgery Drills & Accessories KIT - Narrow Implants

Version/Model Number

GSK002

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

EJL

Product Code Name

Bur, Dental

Public Device Record Key

a7216641-2c7f-4cdf-86fd-fc5a22438a75

Public Version Date

May 24, 2021

Public Version Number

1

DI Record Publish Date

May 16, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-