Catalog Number

-

Brand Name

Synthes

Version/Model Number

310.25

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

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

-

Product Code

HTW

Product Code Name

Bit, Drill

Public Device Record Key

33d87528-e6a5-49d5-9b7c-d86a3138ebd6

Public Version Date

June 03, 2020

Public Version Number

3

DI Record Publish Date

December 12, 2019

Package DI Number

10810041060218

Quantity per Package

10

Contains DI Package

00810041060211

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box