Catalog Number

46100-OS

Brand Name

Ultra DC Oral Surgery Package B

Version/Model Number

46100-OS

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

K970163

Product Code

BSZ

Product Code Name

Gas-Machine, Anesthesia

Public Device Record Key

7231b3d8-aacb-49d3-ba6e-e81e9e6a9a90

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-