Catalog Number

D1.

Brand Name

EXMOOR

Version/Model Number

D1.

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"

-

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

MNK

Product Code Name

Endoscopic Bite Block

Public Device Record Key

a03ad6ab-0f26-4204-9bf8-79bf76140868

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

September 20, 2018

Package DI Number

05060180255213

Quantity per Package

20

Contains DI Package

05060180259228

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

a box