AccessGUDID - DEVICE: OPTIS™ (00812059021390)

GUDID

Device Identifier (DI) Information

Brand Name: OPTIS™
Version or Model: Integrated System E.2 Software
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C408657
Company Name: LIGHTLAB IMAGING, INC.

Primary DI Number: 00812059021390
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 018493531 *Terms of Use

Device Description: Software Upgrade Kit

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?
47490	Coronary optical coherence tomography system	An assembly of optical and computer-based devices that use a broad-bandwidth light beam for optical coherence tomography (OCT) to provide high-resolution images (e.g., 5 to 40 microns) of the coronary intravasculature. It typically consists of a main operator's console which includes a computer for image storage, keyboard/mouse controls, and a visual display unit (VDU); audio recording facilities; and a printer. The system includes an optical-imaging catheter which is connected to the console for transmission of the images from the intravascular site. The system may be used during interventional cardiology, radiology, or diagnostic angiography.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NQQ	SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -25 and 50 Degrees Celsius
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep dry. Do not use if package is damaged.
Storage Environment Temperature: between -25 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 05aa534a-df52-4519-a072-1c0d834ed4e7
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: March 18, 2016