Catalog Number

SC2801.098.

Brand Name

Twist Drill

Version/Model Number

SC2801.098.YJ

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

GFF

Product Code Name

Bur, Surgical, General & Plastic Surgery

Public Device Record Key

ef4f461b-d384-47de-884d-9ce838885d32

Public Version Date

September 26, 2022

Public Version Number

1

DI Record Publish Date

September 16, 2022

Package DI Number

24053613279769

Quantity per Package

1

Contains DI Package

14053613279762

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-