Catalog Number

X-80494B

Brand Name

BISCO LIGHT PROOF RESINVOIR

Version/Model Number

X-80494B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 04, 2020

Issuing Agency

In HIBCC

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

KXR

Product Code Name

Applicator, Resin

Public Device Record Key

067bfc5e-23c1-4548-a024-92f9f36c997e

Public Version Date

February 05, 2020

Public Version Number

2

DI Record Publish Date

October 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-