NA - IRRIGATION ADAPTER for motor handpieces - Richard Wolf GmbH

Duns Number:315304071

Device Description: IRRIGATION ADAPTER for motor handpieces 89955.0000, 89955.00001, 89955.0003 und 89955.000 IRRIGATION ADAPTER for motor handpieces 89955.0000, 89955.00001, 89955.0003 und 89955.00031, reusable

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More Product Details

Catalog Number

163955

Brand Name

NA

Version/Model Number

163955

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

GEY

Product Code Name

MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Device Record Status

Public Device Record Key

bfc3d691-8691-4371-bc1c-dc24411adc86

Public Version Date

May 24, 2021

Public Version Number

1

DI Record Publish Date

May 14, 2021

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