DEVICE: Optical Integrity Laser Fiber (B145103910)

Device Identifier (DI) Information

Optical Integrity Laser Fiber
10391
In Commercial Distribution

OPTICAL INTEGRITY INC
B145103910
HIBCC

1
024050887 *Terms of Use
1000 micrometer laser fiber reusable
CLOSE

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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GEX Powered laser surgical instrument
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
CLOSE

Storage and Handling

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

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: fiber core diameter
Outer Diameter: 1000 Micrometer
CLOSE

Device Record Status

07762afb-cf6e-4122-9948-6f157f05f80a
March 29, 2018
2
August 03, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B145103911 3 B145103910 In Commercial Distribution box
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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