DEVICE: PENTAX (04961333227839)

Device Identifier (DI) Information

PENTAX
FUR-9RBS
In Commercial Distribution

HOYA CORPORATION
04961333227839
GS1

1
691519705 *Terms of Use
Perform cleaning, high-level disinfection, and/or sterilization according to the procedure specified in the Instructions for Use (Reprocessing) of this instrument.
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Device Characteristics

Labeling does not contain MRI Safety Information
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
37111 Flexible fibreoptic ureterorenoscope
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis. It is inserted through the external urethral orifice during a urological procedure. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used for the removal or crushing of stones, pyelitis, and renal failure. This is a reusable device.
Active false
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
K914106 000
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Sterilization

No
Yes
Sterilization Method [?]
Ethylene Oxide
High-level Disinfectant
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

4becae07-045a-4571-aac0-97b7bcf18782
September 27, 2018
4
April 07, 2017
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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
Yes
04961333083633
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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