AccessGUDID - DEVICE: CardioGenesis (00877234000096)

GUDID

Device Identifier (DI) Information

Brand Name: CardioGenesis
Version or Model: NS2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LSR-SG2100S
Company Name: Artivion, Inc.

Primary DI Number: 00877234000096
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119253177 *Terms of Use

Device Description: SolarGen 2100s Holmium:YAG Laser Console

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?
61149	Transmyocardial revascularization solid-state laser system	A 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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNO	System, Laser, Transmyocardial Revascularization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P970029	009
P970029	012
P970029	015
P970029	028
P970029	032

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
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 14 and 30 Degrees Celsius
Handling Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Special Storage Condition, Specify: It 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)

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2a86def5-155e-4651-89ae-8ffe840a37dd
Public Version Date: February 19, 2024
Public Version Number: 4
DI Record Publish Date: December 12, 2016

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: 770-419-3355
Email: xxx@xx.xx

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