DEVICE: NA (04250480106051)

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Device Record History
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Device Identifier (DI) Information
NA
41.0667a
In Commercial Distribution

SCHÖLLY FIBEROPTIC GmbH
04250480106051
GS1

1
316276682 *Terms of Use
UMP Ultra-Mini Nephroscope 1 x 260 mm, 0°
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Device Characteristics
MR Unsafe
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
15290 Rigid optical nephroscope
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the kidney. It is inserted percutaneously into the renal pelvis during nephroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine the internal structures of the kidney and may be used in the removal of renal calculi. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FGA Kit, Nephroscope
FEC Obturator, For Endoscope
FED Endoscopic Access Overtube, Gastroenterology-Urology
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 70 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Insertion tube outer diameter 1mm
Device Size Text, specify: Working length 260mm
Device Size Text, specify: Direction of view 0 degree
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Device Record Status
bc69a735-a807-432f-b007-d79b9cdb228e
November 17, 2023
2
April 17, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
9999999999
info@schoelly-usa.com
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