NITINOL K WIRE TROCAR PIN - NITINOL K WIRE TROCAR PIN - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: NITINOL K WIRE TROCAR PIN

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More Product Details

Catalog Number

-

Brand Name

NITINOL K WIRE TROCAR PIN

Version/Model Number

1106-720

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

3b6e7734-06fe-4b86-81ab-b7d02ac76754

Public Version Date

January 04, 2019

Public Version Number

2

DI Record Publish Date

August 22, 2018

Additional Identifiers

Package DI Number

10192896001760

Quantity per Package

5

Contains DI Package

00192896001763

Package Discontinue Date

-

Package Status

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