FDA UDI
In Commercial Distribution
🇺🇸 United States
Synergy™ Ablation System
DI: 00818354010558
·
Model: OSL2
·
ATRICURE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Synergy™ Ablation System
- Primary DI
- 00818354010558
- Version / Model
- OSL2
- Catalog Number
- A000432
- Company Name
- ATRICURE, INC.
- Labeler DUNS
- 006133784
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 7
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- d2fb790a-e40f-4efe-93cd-49ba5867adf5
Device Description
Isolator Synergy™ Surgical Ablation System Open, Short Jaw, Left Curve
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| OCM | Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60784 | Cardiac radio-frequency ablation system generator | An electrically-powered, noninvasive device intended to be used to generate radio-frequency energy to create ablative lesions in the cardiac tissue of a beating heart in the treatment of cardiac arrhythmias. The generator includes controls and may include electrocardiograph (ECG) interfacing/monitoring functionality. It may be intended to be used with a radio-frequency catheter for endocardial ablation and/or an epicardial probe for epicardial ablation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818354010558 | GS1 |
Customer Contacts
- Phone
- 866-349-2342
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P100046 | 003 |
| P100046 | 004 |
| P100046 | 005 |
| P100046 | 006 |
| P100046 | 007 |
| P100046 | 008 |
| P100046 | 009 |
| P100046 | 010 |