CardioGenesis HP-SG3

GUDID 00877234000102

SoloGrip III Handpiece Delivery System

Cryolife, Inc.

Transmyocardial revascularization laser system beam guide
Primary Device ID00877234000102
NIH Device Record Key1d8eedfc-406a-4f64-ae05-94b765158697
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardioGenesis
Version Model NumberHP-SG3
Catalog NumberHP-SG3
Company DUNS119253177
Company NameCryolife, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone770-419-3355
Emailxxx@xx.xx
Phone770-419-3355
Emailxxx@xx.xx

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *clean, dry environment under conditions that protect against extremes in temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *clean, dry environment under conditions that protect against extremes in temperature and humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100877234000102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNOSystem, Laser, Transmyocardial Revascularization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-12

On-Brand Devices [CardioGenesis]

00877234000119Pearl 5.0 Handpiece Delivery System
00877234000102SoloGrip III Handpiece Delivery System
00877234000096SolarGen 2100s Holmium:YAG Laser Console

Trademark Results [CardioGenesis]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CARDIOGENESIS
CARDIOGENESIS
75912617 not registered Dead/Abandoned
Witt Biomedical Corporation
2000-02-09
CARDIOGENESIS
CARDIOGENESIS
74510959 2099712 Live/Registered
CRYOLIFE, INC.
1994-04-11

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