DEVICE: NA (EOBN270119S0)
Device Identifier (DI) Information
NA
Laser Surgery Fiber - Radial Emission Fiber 600µm Stopper
In Commercial Distribution
OBERON GmbH Fiber Technologies
Laser Surgery Fiber - Radial Emission Fiber 600µm Stopper
In Commercial Distribution
OBERON GmbH Fiber Technologies
Radial Emission Fiber with Stopper, core 550µm, clad 578µm, fiber OD 1400µm, white Tefzel Jacket, SMA 905 connector, PVC protection cap, RFID extension sleeve red, black bend protection, stopper 466mm from distal end, distal conical tip with silica capillary dome 1800µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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62600 | General/multiple surgical laser system beam guide, single-use |
A surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GEX | Powered Laser Surgical Instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K140470 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a0adb05b-b6e8-44f3-8c38-5e4d7439a809
June 02, 2023
3
January 15, 2019
June 02, 2023
3
January 15, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined