FDA.reportPublic FDA data

OPTIS™

Primary DI
00812059020003
Brand
OPTIS™
Company
LIGHTLAB IMAGING, INC.
Model
Integrated System
Catalog number
C408654
Device description
Installation Kit
Published
2017-07-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC
NQQSYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2
NQQSystem, Imaging, Optical Coherence Tomography (Oct)Radiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812059020003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812059020003008120590200038120590200030812059020003

GMDN Terms#

Term, Definition table
TermDefinition
Coronary optical coherence tomography systemAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-25 Degrees Celsius50 Degrees Celsius
Special Storage Condition, Specify00Keep dry.
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
018493531
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067054920Ultreon™ULTR300001ULTR3000012026-05-19
05415067053879ILUMIEN™ OPTIS™ to OPTIS™UIMG901003UIMG9010032025-07-31
05415067047694Ultreon™101531010153102024-03-29
05415067025715PressureWire™C12059C120592016-08-19
05415067025739PressureWire™C12009C120092016-08-19
05415067025722PressureWire™C12359C123592016-08-19
05415067048882AptiVue™101520910152092023-09-29
00183739000647Dragonfly™ OPTIS™C408645C4086452015-04-20
00183739000654Dragonfly™ OPTIS™C408646C4086462015-04-20
05415067037626Ultiri™101508210150822022-08-12
05415067031129Dragonfly OpStar™101465110146512019-12-17
00183739000678ILUMIEN™C408650C4086502016-03-23
00812059020126OPTIS™C408653C4086532015-09-28
05415067030856AptiVue™101466610146662020-10-26
00183739000937OPTIS™Integrated SystemC4086522015-09-28
00812059021420OPTIS™Mobile SystemC4086612015-12-21
00183739000562C7 Dragonfly™100-100-00100-100-002015-04-17
00183739000623Dragonfly™Kit100-100-KT2015-04-20
00183739000630ILUMIEN™900-700-00900-700-002016-03-23
00183739000692Dragonfly™Duo KitC4086432015-04-20

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08714729200581Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
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