DEVICE: FlexGuard Laser Fiber with Extended Length Sheath (B14527750300U1SH0)

Device Identifier (DI) Information

FlexGuard Laser Fiber with Extended Length Sheath
27750300U1SH
Not in Commercial Distribution

OPTICAL INTEGRITY INC
B14527750300U1SH0
HIBCC
March 28, 2017
1
024050887 *Terms of Use
300 micrometer FlexGuard fiber with extended length sheath
CLOSE

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.
CLOSE

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K100194 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
CLOSE

Storage and Handling

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

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: fiber core diameter
Outer Diameter: 300 Micrometer
CLOSE

Device Record Status

9b2d1613-585f-401f-a22e-9cc535427f66
July 06, 2018
4
July 28, 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
B14527750300U13SH1 3 B14527750300U1SH0 2017-03-28 Not 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)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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