DEVICE: n.a. (04048551402528)

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Device Record History
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Device Identifier (DI) Information
n.a.
11272VNIA
In Commercial Distribution

Karl Storz GmbH & Co. KG
04048551402528
GS1

1
315731430 *Terms of Use
Flexible Video Urethro-Cystoscope, PDD
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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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
32019 Flexible video cystourethroscope
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urethra, including the prostate region. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during an endourologic procedure. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. It is used for biopsy, removal of small stones, treatment of lesions of the urinary bladder/posterior urethra, or to evaluate bladder control/incontinence. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OAY Light Source System, Diagnostic Endoscopic
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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 [?]
Hydrogen Peroxide
Ethylene Oxide
Peracetic Acid
High-level Disinfectant
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Storage and Handling

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

[?]
Size Type Text
No Device Sizes
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Device Record Status
065087e1-269b-46a0-983c-26c64127800a
August 19, 2024
6
May 30, 2018
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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

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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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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