Mauser WIVA 4 - 12 Gallon Red BioHaz Sharps Disposable Container - Envirotain, LLC

Duns Number:080390642

Device Description: 12 Gallon Red BioHaz Sharps Disposable Container w/Standard Lid

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More Product Details

Catalog Number

-

Brand Name

Mauser WIVA 4

Version/Model Number

NL050V4080ROST

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K170513

Product Code Details

Product Code

MMK

Product Code Name

Container, Sharps

Device Record Status

Public Device Record Key

f0ae0dd2-40ee-4b74-8ea2-fe986577441e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 15, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ENVIROTAIN, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 36