Sure-Trap - Overflow Safety Trap - OHIO MEDICAL, LLC

Duns Number:005192885

Device Description: Overflow Safety Trap

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More Product Details

Catalog Number

-

Brand Name

Sure-Trap

Version/Model Number

70365

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

KDP

Product Code Name

Regulator, Vacuum

Device Record Status

Public Device Record Key

ab49f3cf-169e-4f31-8151-b3100232c4d5

Public Version Date

May 08, 2020

Public Version Number

1

DI Record Publish Date

April 30, 2020

Additional Identifiers

Package DI Number

00628101609528

Quantity per Package

12

Contains DI Package

00628101609511

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"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