FDA.reportPublic FDA data

The Heart Laser Disposable TMR kit

Primary DI
00860701000101
Brand
The Heart Laser Disposable TMR kit
Company
Novadaq Technologies Inc
Model
AC00012
Device description
Sterile disposable kit which includes TMR handpieces, arm drape, cleaning swabs, heart diagram and markers
Published
2014-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNOSystem, Laser, Transmyocardial Revascularization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNOSystem, Laser, Transmyocardial RevascularizationUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860701000101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860701000101008607010001018607010001010860701000101

GMDN Terms#

Term, Definition table
TermDefinition
Transmyocardial revascularization laser system beam guideA sterile, flexible, probe-like device intended to be connected to a cardiac laser system for the delivery of laser energy directly onto the heart during transmyocardial revascularization surgery (open surgical approach). It includes fibreoptic materials whereby a distal laser fibre of a specific width is intended to penetrate myocardium to create channels for the promotion of angiogenesis; it may include distal needles/tubing to allow injection of agents into the myocardium. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00store in cool, dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-230-3352xxx@xxx.xxx

Regulatory Flags#

DUNS number
243730939
Device count
1
Kit
true
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
00858701006568PINPOINTPC9004PC90042018-12-12
00858701006025SPYLC3000LC30002016-09-23
00858701006032LUNALU3000LU30002016-09-23
00858701006551PINPOINTPC9002PC90022018-12-12
10858701006251SPY®ND30102017-01-30
10858701006329SPY-PHI SystemHH20002017-03-31
10858701006299NOVADRAPE®ND80002018-01-08
10858701006268SPY PAQLC3006LC30062016-09-23
10858701006282SPY-PHI SystemHH9001HH90062017-03-31
10858701006176PINPOINT PAQPP9031PP90362016-09-23
20858701006326SPY-PHI SystemHH20002017-03-31
00858701006049NOVADAQ and PINPOINTPC9000PC90012016-09-23
00858701006056NOVADAQ and PINPOINTSC9104SC91042016-09-23
00858701006063NOVADAQ and PINPOINTSC9134SC91342016-09-23
00858701006070NOVADAQ and PINPOINTSC9144SC91442016-09-23
00858701006124NOVADAQ and PINPOINTSC9504SC95042016-09-23
00858701006131NOVADAQ and PINPOINTSC9534SC95342016-09-23
00858701006193SPY-PHI SystemHH9000HH90302017-03-31
00858701006209NOVADAQ and PINPOINTSC9544SC95442016-09-23
10858701006220PINPOINT PAQ® PP90922016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551425695n.a.Karl Storz GmbH & Co. KGMNO2024-12-20
00877234000096CardioGenesisArtivion, Inc.MNO2016-12-12
00877234000102CardioGenesisArtivion, Inc.MNO2016-12-12
00877234000119CardioGenesisArtivion, Inc.MNO2016-12-12