DEVICE: Optical Integrity Laser Fiber (B145114960)

Device Identifier (DI) Information

Optical Integrity Laser Fiber
11496
In Commercial Distribution

OPTICAL INTEGRITY INC
B145114960
HIBCC

1
024050887 *Terms of Use
550 micrometer laser fiber with extension sleeve, reusable, nonsterile
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
General/multiple surgical laser system beam guide, reusable A flexible, probe-like 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 typically consists of fibreoptic materials with an invasive laser-firing distal end. This is a reusable device intended to be sterilized prior to use.
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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 [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
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
Device Size Text, specify: fiber core diameter
Outer Diameter: 550 Micrometer
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Device Record Status

6514b87a-ae5a-4eaf-bd1d-f87e76239add
March 29, 2018
2
December 06, 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
B145114961 3 B145114960 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)

[?]
Yes
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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