Dragonfly™

Primary DI
00183739000692
Brand
Dragonfly™
Company
LIGHTLAB IMAGING, INC.
Model
Duo Kit
Catalog number
C408643
Device description
Imaging Catheter
Published
2015-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ORDOptical coherence tomography, intravascular catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORDOptical Coherence Tomography, Intravascular CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00183739000692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00183739000692001837390006921837390006920183739000692

GMDN Terms#

Term, Definition table
TermDefinition
Coronary optical coherence tomography system catheterA sterile flexible tube with an extremely fine working end that houses an optical fibre and imaging lens intended to be transcutaneously introduced into the coronary vasculature to perform coronary optical coherence tomography (OCT). The proximal end of the device connects to a coronary OCT console for the transmission of high-resolution images (e.g., 5 to 40 micron) of the coronary intravasculature. It is typically made of stainless steel, plastic, and optical materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge2.7French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE IN DARK, DRY PLACE

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
Expiration 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
00183739000708Dragonfly™DuoC4086442015-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860008045508Starlight Imaging CatheterSpectrawave, Inc.ORD2024-02-23
00860008045515HyperVue Imaging SystemSpectrawave, Inc.ORD2024-02-23
00183739000623Dragonfly™LIGHTLAB IMAGING, INC.ORD2015-04-20
00183739000708Dragonfly™LIGHTLAB IMAGING, INC.ORD2015-04-20
00183739000562C7 Dragonfly™LIGHTLAB IMAGING, INC.ORD2015-04-17