Catalog Number

485-548

Brand Name

DAVIS MOUTH GAG FRAME

Version/Model Number

485-548

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LRC

Product Code Name

INSTRUMENT, ENT MANUAL SURGICAL

Public Device Record Key

b13b2c5d-7967-46dd-8895-c085cf7ce46d

Public Version Date

October 22, 2018

Public Version Number

2

DI Record Publish Date

September 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-