RIWO D-URS - SENSOR-URETERORENOSCOPE 9FR WL 600MM flexible, - Richard Wolf GmbH

Duns Number:315304071

Device Description: SENSOR-URETERORENOSCOPE 9FR WL 600MM flexible, working channel 1: 3,6FR, working channel SENSOR-URETERORENOSCOPE 9FR WL 600MM flexible, working channel 1: 3,6FR, working channel 2: 1,65FR, PU= 3 pcs, sterile, for single use

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More Product Details

Catalog Number

473572076

Brand Name

RIWO D-URS

Version/Model Number

473572076

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

K201897,K201897

Product Code Details

Product Code

FGB

Product Code Name

Ureteroscope and accessories, flexible/rigid

Device Record Status

Public Device Record Key

8292d003-822f-4b30-9dc2-5472364b52f2

Public Version Date

May 25, 2021

Public Version Number

1

DI Record Publish Date

May 17, 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