AccessGUDID - DEVICE: CardioGenesis (00877234000119)

GUDID

Device Identifier (DI) Information

Brand Name: CardioGenesis
Version or Model: HP-PRL5
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HP-PRL5
Company Name: Artivion, Inc.

Primary DI Number: 00877234000119
Issuing Agency: GS1
Commercial Distribution End Date: May 08, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 119253177 *Terms of Use

Device Description: Pearl 5.0 Handpiece Delivery System

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":	Yes
For Single-Use:	Yes
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?
61171	Transmyocardial revascularization laser system beam guide	A 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.	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	011
P970029	013
P970029	015
P970029	017
P970029	018
P970029	019
P970029	020
P970029	024
P970029	026
P970029	029

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: clean, dry environment under conditions that protect against extremes in temperature and humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2785ad9d-59a7-435d-9e0b-de09dedf4bf9
Public Version Date: February 19, 2024
Public Version Number: 4
DI Record Publish Date: December 12, 2016