Catalog Number

VK.J1001CTBC

Brand Name

Quick Release

Version/Model Number

VK.J1001CTBC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

HAE

Product Code Name

RONGEUR, MANUAL

Public Device Record Key

f1e768fa-55bc-458e-b616-5c80257ebbb0

Public Version Date

June 25, 2019

Public Version Number

1

DI Record Publish Date

June 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-