DEVICE: E-LINE (04055207020043)

Device Identifier (DI) Information

E-LINE
8703514
In Commercial Distribution
8703.514
Richard Wolf GmbH
04055207020043
GS1

1
315304071 *Terms of Use
URETERORENOSCOPE 12° 8/9.8FR WL 430MM semi-rigid, with straight ocular lens, working channel 1x5 (2x3)Fr, atraumatic distal tip, TL 558mm, fiber image carrier
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Rigid ureterorenoscope An endoscope with a rigid or semi-rigid inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis; some types may have a flexible tip at the distal end of the inserted portion. It is inserted through the external urethral orifice during a urological procedure whereby anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is commonly used for the crushing or removal of stones and evaluation of pyelitis or renal failure. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
FGB Ureteroscope and accessories, flexible/rigid
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
Yes
Sterilization Method [?]
Hydrogen Peroxide
Ethylene Oxide
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Length: 430 Millimeter
Angle: 12 degree
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Device Record Status

9f9eedfd-52a6-4293-8c3f-279e0b82aa42
July 06, 2018
3
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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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

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No
Yes
No
No
No CLOSE

Customer Contact

[?]
+497043350
info@richard-wolf.com
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