DEVICE: ScopeSafe™Laser Fiber (B145107190)

Device Identifier (DI) Information

ScopeSafe™Laser Fiber
10719
In Commercial Distribution

OPTICAL INTEGRITY INC
B145107190
HIBCC

1
024050887 *Terms of Use
300 micrometer ScopeSafe laser 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 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 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. 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 [?]
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

714da91e-9959-4620-a0ad-b510a4faf2a6
July 06, 2018
4
July 28, 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
B145107191 3 B145107190 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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