NA - Uretero-Renoscope 7.5 Fr. x 425 mm, Working - SCHÖLLY FIBEROPTIC GmbH

Duns Number:316276682

Device Description: Uretero-Renoscope 7.5 Fr. x 425 mm, Working channel 5 Fr.

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

41.0609a.wol

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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)

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

FGB

Product Code Name

Ureteroscope And Accessories, Flexible/Rigid

Device Record Status

Public Device Record Key

f460305e-f883-48b4-92bf-69d914560130

Public Version Date

August 17, 2018

Public Version Number

1

DI Record Publish Date

July 17, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCHÖLLY FIBEROPTIC GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 128