Quick Release - QUICK RELEASE Micro Kerrison Rongeur, THIN - Vitalitec International Medizintechnik GmbH

Duns Number:328485453

Device Description: QUICK RELEASE Micro Kerrison Rongeur, THIN footplate, 12 mm bite opening, 40d UP, 4 QUICK RELEASE Micro Kerrison Rongeur, THIN footplate, 12 mm bite opening, 40d UP, 4 mm, 7"

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More Product Details

Catalog Number

VK.J704CT

Brand Name

Quick Release

Version/Model Number

VK.J704CT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

Product Code Details

Product Code

HAE

Product Code Name

RONGEUR, MANUAL

Device Record Status

Public Device Record Key

37a74bed-af70-4fe1-aa30-226ea8066d96

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 28, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VITALITEC INTERNATIONAL MEDIZINTECHNIK GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 228