DEVICE: Flex-G Fiber with Sheath (B145111110)

Device Identifier (DI) Information

Flex-G Fiber with Sheath
11111
In Commercial Distribution

OPTICAL INTEGRITY INC
B145111110
HIBCC

1
024050887 *Terms of Use
300 micrometer Flex-G Fiber with Sheath
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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. 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?
61474 General/multiple surgical laser system beam guide, reusable
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 reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GEX Powered laser surgical instrument
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K100194 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 37 Degrees Celsius
Special Storage Condition, Specify: store at room temperature
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 300 Micrometer
Device Size Text, specify: fiber core diameter
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Device Record Status

5177876b-70c7-47ef-ad95-28ce2fe6c6ad
June 02, 2023
6
December 19, 2016
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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
B145111131 3 B145111110 In Commercial Distribution box
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
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
Yes
No CLOSE

Customer Contact

[?]
+1(850)233-5512
customercare@opticalintegrity.com
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