NA - UMP Ultra-Mini Nephroscope 1 x 260 mm, 0° - SCHÖLLY FIBEROPTIC GmbH

Duns Number:316276682

Device Description: UMP Ultra-Mini Nephroscope 1 x 260 mm, 0°

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

41.0667a

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

FEC

Product Code Name

Obturator, For Endoscope

Device Record Status

Public Device Record Key

bc69a735-a807-432f-b007-d79b9cdb228e

Public Version Date

April 27, 2020

Public Version Number

1

DI Record Publish Date

April 17, 2020

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