Catalog Number

-

Brand Name

MediChoice

Version/Model Number

BBK1001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

For Single-Use

Yes

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

MNK

Product Code Name

Endoscopic bite block

Public Device Record Key

05850d8a-986a-4b0f-9111-b5aa58f4a1f1

Public Version Date

October 16, 2020

Public Version Number

1

DI Record Publish Date

October 08, 2020

Package DI Number

50885632107557

Quantity per Package

50

Contains DI Package

10885632107559

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-