BOEHRINGER® 3/16" PVC Drain & Trocar - 3/16" PVC Drain & Trocar - BOEHRINGER LABORATORIES, LLC

Duns Number:079991657

Device Description: 3/16" PVC Drain & Trocar

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More Product Details

Catalog Number

2063

Brand Name

BOEHRINGER® 3/16" PVC Drain & Trocar

Version/Model Number

2063

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2017

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"

Yes

For Single-Use

Yes

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

CAC

Product Code Name

Apparatus, Autotransfusion

Device Record Status

Public Device Record Key

7ff5fc7f-adbf-4b50-b993-afbe0382a775

Public Version Date

March 08, 2022

Public Version Number

5

DI Record Publish Date

August 01, 2016

Additional Identifiers

Package DI Number

50816286020701

Quantity per Package

12

Contains DI Package

10816286020703

Package Discontinue Date

December 31, 2017

Package Status

Not in Commercial Distribution

Package Type

Box

"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