FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CardioGenesis
DI: 00877234000119
·
Model: HP-PRL5
·
Artivion, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CardioGenesis
- Primary DI
- 00877234000119
- Version / Model
- HP-PRL5
- Catalog Number
- HP-PRL5
- Company Name
- Artivion, Inc.
- Labeler DUNS
- 119253177
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-12
- Public Version
- 4
- Public Version Date
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- 2785ad9d-59a7-435d-9e0b-de09dedf4bf9
- Distribution End Date
- 2017-05-08
Device Description
Pearl 5.0 Handpiece Delivery System
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MNO | System, Laser, Transmyocardial Revascularization | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00877234000119 | GS1 |
Customer Contacts
- Phone
- 770-419-3355
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P970029 | 011 |
| P970029 | 013 |
| P970029 | 015 |
| P970029 | 017 |
| P970029 | 018 |
| P970029 | 019 |
| P970029 | 020 |
| P970029 | 024 |
| P970029 | 026 |
| P970029 | 029 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- clean, dry environment under conditions that protect against extremes in temperature and humidity