PIN SCREW - Cancellous Pin Screw, 6mm Shaft Diameter x 6mm - BK MEDITECH CO.,LTD.

Duns Number:687941818

Device Description: Cancellous Pin Screw, 6mm Shaft Diameter x 6mm Thread Diameter x 130mm Total Length x 60mm Cancellous Pin Screw, 6mm Shaft Diameter x 6mm Thread Diameter x 130mm Total Length x 60mm Thread Length

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More Product Details

Catalog Number

-

Brand Name

PIN SCREW

Version/Model Number

31860-60-13

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

K061599

Product Code Details

Product Code

JDW

Product Code Name

Pin, Fixation, Threaded

Device Record Status

Public Device Record Key

a70b0825-3b31-41c6-9e48-3aa9ef8bd791

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BK MEDITECH CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4455