Catalog Number

46200-OS-ADJT

Brand Name

Ultra DC Oral Surgery Package C ADJT

Version/Model Number

46200-OS-ADJT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

March 22, 2099

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

K052335

Product Code

BSZ

Product Code Name

Gas-Machine, Anesthesia

Public Device Record Key

d4481986-f71f-4bc9-a2f3-0663234f65ab

Public Version Date

April 01, 2019

Public Version Number

1

DI Record Publish Date

March 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-