Catalog Number

ML1115/B

Brand Name

Preston™

Version/Model Number

00884450412015

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)

-

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

fd0bde17-118b-4188-9f56-958d96c3a207

Public Version Date

March 05, 2021

Public Version Number

1

DI Record Publish Date

February 25, 2021

Package DI Number

10884450412012

Quantity per Package

14

Contains DI Package

00884450412015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-