FDA.reportPublic FDA data

CardioGenesis

Primary DI
00877234000096
Brand
CardioGenesis
Company
Artivion, Inc.
Model
NS2000
Catalog number
LSR-SG2100S
Device description
SolarGen 2100s Holmium:YAG Laser Console
Published
2016-12-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P970029009
P970029012
P970029015
P970029028
P970029032

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970029009TMR HOLMIUM LASER SYSTEMCryolife, Inc.1999-02-11MNO
P970029012TMR HOLMIUM LASER SYSTEMCryolife, Inc.1999-02-11MNO
P970029015TMR HOLMIUM LASER SYSTEMCryolife, Inc.1999-02-11MNO
P970029028TMR HOLMIUM LASER SYSTEMCryolife, Inc.1999-02-11MNO
P970029032TMR HOLMIUM LASER SYSTEMCryolife, Inc.1999-02-11MNO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00877234000096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00877234000096008772340000968772340000960877234000096

GMDN Terms#

Term, Definition table
TermDefinition
Transmyocardial revascularization solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod [typically yttrium-aluminium-garnet doped with holmium (Ho:YAG)] to emit a high-power laser beam intended for transmyocardial revascularization surgical procedures (open surgical approach); it does not include frequency-doubling technology. It includes a light source, controls/foot-switch and may include the handpiece/guide. It emits a midinfrared wavelength, and may be used with a handpiece capable of injecting agents/materials into the heart (e.g., stem cells).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Special Storage Condition, Specify00It is recommended that the laser console be covered when stored and never stored in an area at or below freezing temperature (less than or equal to 0°C or 32°F)
Special Storage Condition, Specify00It is recommended that the laser console be covered when stored and never stored in an area at or below freezing temperature (≤0°C or ≤32°F)
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature14 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-419-3355xxx@xx.xx
770-419-3355RA-KSW@artivion.com

Regulatory Flags#

DUNS number
119253177
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00877234001635PhotoFix Decellularized Bovine PericardiumPFP6X8PFP6X82026-05-29
00877234001642PhotoFix Decellularized Bovine PericardiumPFP0.8X8PFP0.8X82026-05-29
00877234001659PhotoFix Decellularized Bovine PericardiumPFP1X6PFP1X62026-05-29
00877234001666PhotoFix Decellularized Bovine PericardiumPFP4X4PFP4X42026-05-29
00877234001673PhotoFix Decellularized Bovine PericardiumPFP2X9PFP2X92026-05-29
00877234001680PhotoFix Decellularized Bovine PericardiumPFP1X10PFP1X102026-05-29
00877234001697PhotoFix Decellularized Bovine PericardiumPFP1X14PFP1X142026-05-29
00877234001703PhotoFix Decellularized Bovine PericardiumPFP8X14PFP8X142026-05-29
00877234000447CryoValve® SG Pulmonary Human Heart Valve SGPV00SGPV002015-09-11
00877234000454CryoValve® SG Pulmonary Human Heart Valve SGPV10SGPV102015-09-11
00877234000102CardioGenesisHP-SG3HP-SG32016-12-12
00877234001192"AMDS Hybrid Prosthesis (""AMDS"")"K039420AMDS40 2025-02-05
00877234001208"AMDS Hybrid Prosthesis (""AMDS"")"K039421AMDS4030 2025-02-05
00877234001215"AMDS Hybrid Prosthesis (""AMDS"")"K039422AMDS55 2025-02-05
00877234001222"AMDS Hybrid Prosthesis (""AMDS"")"K039423AMDS55402025-02-05
00877234001321"AMDS Hybrid Prosthesis (""AMDS"")"K038896AMDS4030c 2025-02-05
00877234001338"AMDS Hybrid Prosthesis (""AMDS"")"K038895AMDS40c 2025-02-05
10877234001298BioGlue Surgical AdhesiveBG3510-5-USBG3510-5-US2024-03-13
10877234001304BioGlue Surgical AdhesiveBG3515-5-USBG3515-5-US2024-03-13
00877234000898BioGlue Surgical AdhesiveBGAT-27-SYBGAT-27-SY2024-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551425695n.a.Karl Storz GmbH & Co. KGMNO2024-12-20
00877234000102CardioGenesisArtivion, Inc.MNO2016-12-12
00877234000119CardioGenesisArtivion, Inc.MNO2016-12-12
00860701000101The Heart Laser Disposable TMR kitNovadaq Technologies IncMNO2014-09-17