DEVICE: Flex-G Fiber with Sheath Calculase compatible (B145110940)
Device Identifier (DI) Information
Flex-G Fiber with Sheath Calculase compatible
11094
In Commercial Distribution
OPTICAL INTEGRITY INC
11094
In Commercial Distribution
OPTICAL INTEGRITY INC
272 micrometer Flex-G Fiber with Sheath Calculase compatible
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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Device Size Text, specify: fiber core diameter |
Outer Diameter: 272 Micrometer |
Device Record Status
7860e23f-f3fd-4c89-b314-15dc53e5c650
June 02, 2023
6
December 19, 2016
June 02, 2023
6
December 19, 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 |
---|---|---|---|---|---|
B145110961 | 3 | B145110940 | 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