NA - BOTTLE CAP/INSERT reusable - Richard Wolf GmbH

Duns Number:315304071

Device Description: BOTTLE CAP/INSERT reusable

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More Product Details

Catalog Number

8228.803

Brand Name

NA

Version/Model Number

8228803

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

-

Prescription Use (Rx)

-

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

KQT

Product Code Name

EVACUATOR, GASTRO-UROLOGY

Device Record Status

Public Device Record Key

da1910a8-fe9a-4bb7-bb02-04fd388de4a0

Public Version Date

January 08, 2021

Public Version Number

6

DI Record Publish Date

September 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RICHARD WOLF GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 587
2 A medical device with a moderate to high risk that requires special controls. 1835