BOEHRINGER® Regulator Washer - Regulator Washer - BOEHRINGER LABORATORIES, LLC

Duns Number:079991657

Device Description: Regulator Washer

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More Product Details

Catalog Number

7992

Brand Name

BOEHRINGER® Regulator Washer

Version/Model Number

7992

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 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

KDP

Product Code Name

Regulator, Vacuum

Device Record Status

Public Device Record Key

ea19ab0f-a531-4f48-b8a1-092b98f8fa57

Public Version Date

December 22, 2020

Public Version Number

4

DI Record Publish Date

September 07, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BOEHRINGER LABORATORIES, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 85