Zimmer Cannulated Screw System - CANNULATED DRILL, 3.2mm TRINKLE - Pioneer Surgical Technology, Inc.

Duns Number:793384496

Device Description: CANNULATED DRILL, 3.2mm TRINKLE

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More Product Details

Catalog Number

00-1147-027-00

Brand Name

Zimmer Cannulated Screw System

Version/Model Number

00-1147-027-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

HTW

Product Code Name

BIT, DRILL

Device Record Status

Public Device Record Key

ebe439f1-dc61-47e6-bf4d-1c4c2436910e

Public Version Date

October 14, 2021

Public Version Number

2

DI Record Publish Date

September 25, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PIONEER SURGICAL TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3116
2 A medical device with a moderate to high risk that requires special controls. 5221