Catalog Number

-

Brand Name

INORIS MEDICAL

Version/Model Number

IM-50

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

Yes

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

3dbb2577-2df8-4d19-93c5-971a0eef27fa

Public Version Date

January 20, 2021

Public Version Number

1

DI Record Publish Date

January 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-