Catalog Number

35.009.20QL

Brand Name

Litho standard obturator for 35.009.10QL

Version/Model Number

35.009.20QL

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"

Yes

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

JFL

Product Code Name

PH RATE MEASUREMENT, CARBON-DIOXIDE

Public Device Record Key

e3be61cd-55d6-49dc-a35a-083a96bae5f3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 03, 2016

Package DI Number

EMAH3500920QL1

Quantity per Package

1

Contains DI Package

EMAH3500920QL0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-