AccessGUDID - DEVICE: OPTIS™ (00812059020126)

GUDID

Device Identifier (DI) Information

Brand Name: OPTIS™
Version or Model: C408653
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C408653
Company Name: LIGHTLAB IMAGING, INC.

Primary DI Number: 00812059020126
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 018493531 *Terms of Use

Device Description: Mobile Workstation

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 Temperature: between -25 and 50 Degrees Celsius
Special Storage Condition, Specify: Keep Dry. Do not use the OPTIS Mobile System if it has been dropped or in another way exposed to mechanical or electrical damage or if liquids have penetrated the housing.
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between .05 and .106 KiloPascal
Handling Environment Atmospheric Pressure: between .05 and .106 KiloPascal
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: bde9f15d-efec-4c05-bb94-d17745a9e0eb
Public Version Date: November 16, 2020
Public Version Number: 3
DI Record Publish Date: September 28, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(855)478-5833
Email: customerservice@sjm.com

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