DEVICE: IEC-Innoview GmbH (B192300054000)

Device Identifier (DI) Information

IEC-Innoview GmbH
30-0054-00
In Commercial Distribution
30-0054-00
INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.
B192300054000
HIBCC

1
010741028 *Terms of Use
2.7 mm, 30 deg. Cystoscope, l=302mm, autoclavable
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
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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 cystoscope An endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. 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 cystoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. It is used to examine/diagnose incontinence, the inability to pass urine (retention), recurrent urinary tract infections, to remove tissue samples/stones/small tumours from the bladder, and for removal of the prostate. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
FAJ Cystoscope 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 [?]
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: 302 Millimeter
Outer Diameter: 2.7 Millimeter
Angle: 30 degree
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Device Record Status

8d8ea081-dd40-4a0c-8caa-e652a50d9b3a
March 29, 2018
2
June 02, 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)

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Yes
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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