Catalog Number

704-954

Brand Name

Pomee

Version/Model Number

704-954

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

EMJ

Product Code Name

Elevator, Surgical, Dental

Public Device Record Key

d4751ec0-b8b9-4870-a4b5-ff29561dbb9d

Public Version Date

January 06, 2022

Public Version Number

1

DI Record Publish Date

December 29, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-