Surgical Free Flow Vacuum Regulator - Vacuum Regulator, Surgical Free Flow, 760mmHg - OHIO MEDICAL, LLC

Duns Number:005192885

Device Description: Vacuum Regulator, Surgical Free Flow, 760mmHg Analog

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More Product Details

Catalog Number

-

Brand Name

Surgical Free Flow Vacuum Regulator

Version/Model Number

SCHA

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 30, 2020

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

GCX

Product Code Name

Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Device Record Status

Public Device Record Key

3cf56ced-2fb0-4b8b-8f06-24ad8d5deb45

Public Version Date

April 30, 2020

Public Version Number

5

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OHIO MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6453
2 A medical device with a moderate to high risk that requires special controls. 208