AccessGUDID - DEVICE: Optical Integrity Laser Fiber (B145P00120550R0)

GUDID

Device Identifier (DI) Information

Brand Name: Optical Integrity Laser Fiber
Version or Model: P00120550R
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: OPTICAL INTEGRITY INC

Primary DI Number: B145P00120550R0
Issuing Agency: HIBCC
Commercial Distribution End Date: March 28, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 024050887 *Terms of Use

Device Description: 550 micrometer laser fiber reusable

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered laser surgical instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K022338	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 550 Micrometer
Device Size Text, specify: fiber core diameter

Device Record Status

Public Device Record Key: ecd1c149-cf4a-4413-9671-b01a85cd72b6
Public Version Date: June 02, 2023
Public Version Number: 6
DI Record Publish Date: July 28, 2016