DEVICE: ScopeSafe™Laser Fiber (B145107190)
Device Identifier (DI) Information
ScopeSafe™Laser Fiber
10719
In Commercial Distribution
OPTICAL INTEGRITY INC
10719
In Commercial Distribution
OPTICAL INTEGRITY INC
300 micrometer ScopeSafe laser fiber with Sheath
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. 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEX | Powered laser surgical instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K100194 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 10 and 37 Degrees Celsius |
Special Storage Condition, Specify: store at room temperature |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 300 Micrometer |
Device Size Text, specify: fiber core diameter |
Device Record Status
714da91e-9959-4620-a0ad-b510a4faf2a6
June 02, 2023
6
July 28, 2016
June 02, 2023
6
July 28, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
+1(850)233-5512
customercare@opticalintegrity.com
customercare@opticalintegrity.com