NITINOL K WIRE TROCAR PIN - NITINOL K WIRE TROCAR PIN WITH ROUND END - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: NITINOL K WIRE TROCAR PIN WITH ROUND END

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More Product Details

Catalog Number

-

Brand Name

NITINOL K WIRE TROCAR PIN

Version/Model Number

1106-719

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K100736,K100736,K100736

Product Code Details

Product Code

HTY

Product Code Name

Pin, Fixation, Smooth

Device Record Status

Public Device Record Key

902d7f1d-ae88-4c1d-bc12-161f679a15f0

Public Version Date

December 04, 2018

Public Version Number

2

DI Record Publish Date

August 22, 2018

Additional Identifiers

Package DI Number

10192896001746

Quantity per Package

1

Contains DI Package

00192896001749

Package Discontinue Date

December 03, 2018

Package Status

Not in Commercial Distribution

Package Type

Inner Pack

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414