VERTEBRIS - TREPHINE Ø 5.3MM WL 200MM sharp, reusable - Richard Wolf GmbH

Duns Number:315304071

Device Description: TREPHINE Ø 5.3MM WL 200MM sharp, reusable

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More Product Details

Catalog Number

8792.504

Brand Name

VERTEBRIS

Version/Model Number

8792504

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)

-

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

HWK

Product Code Name

TREPHINE

Device Record Status

Public Device Record Key

756b72a4-605b-407a-955e-7e62e2916546

Public Version Date

August 17, 2022

Public Version Number

1

DI Record Publish Date

August 09, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RICHARD WOLF GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 587
2 A medical device with a moderate to high risk that requires special controls. 1835