DEVICE: OlyCath Curved 0 Eye 7 French (03700512967996)

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Device Record History
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Device Identifier (DI) Information
OlyCath Curved 0 Eye 7 French
ROTH7000ST245
In Commercial Distribution
OLCAC07
Promepla
03700512967996
GS1

1
401020409 *Terms of Use
Ureteral catheter, L. 80cm curved open, without eye, 07 CH/Fr
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
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?
34926 Ureteral catheter
A flexible tube designed for introduction into the ureters through a cystoscope, ureteroscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double-lumen and graduated markings. The device is used for ureter dilation, bypass of partial obstructions, urinary tract irrigation/drainage during surgery (e.g., injection of contrast agent, anaesthetic agent and/or antiretropulsion gel), stone removal, retrograde urography, guidewire placement, and/or brush biopsy. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EYB Catheter, Ureteral, Gastro-Urology
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K192183 000
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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
86d5aa0c-01b0-4459-9d25-0ffe1f4f5b0d
January 15, 2024
2
May 06, 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
03700512977995 10 03700512967996 In Commercial Distribution Box 1
03700512987994 6 03700512977995 In Commercial Distribution Box 2
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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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