STEINMANN PIN PACKAGE - STEINMANN PIN PACKAGE OF 6 DOUBLE ENDED SMOOTH - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: STEINMANN PIN PACKAGE OF 6 DOUBLE ENDED SMOOTH TROCAR TIP

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More Product Details

Catalog Number

1106-505

Brand Name

STEINMANN PIN PACKAGE

Version/Model Number

1106-505

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"

Yes

For Single-Use

-

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

K100736

Product Code Details

Product Code

HTY

Product Code Name

Pin, Fixation, Smooth

Device Record Status

Public Device Record Key

d359e28a-9e6f-4ca1-a14f-dcbea5b6000e

Public Version Date

June 25, 2019

Public Version Number

1

DI Record Publish Date

June 17, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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