VICKERS EASY DRIVER - VICKERS EASY DRIVER - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: VICKERS EASY DRIVER

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More Product Details

Catalog Number

1103-179

Brand Name

VICKERS EASY DRIVER

Version/Model Number

1103-179

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

-

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

GFC

Product Code Name

DRIVER, SURGICAL, PIN

Device Record Status

Public Device Record Key

12c7d473-4924-4f91-b76f-2d98e556897b

Public Version Date

March 10, 2020

Public Version Number

5

DI Record Publish Date

September 17, 2018

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