FDA UDI
In Commercial Distribution
🇺🇸 United States
Synergy™ Ablation System
DI: 10840143901584
·
Model: ASB3
·
ATRICURE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Synergy™ Ablation System
- Primary DI
- 10840143901584
- Version / Model
- ASB3
- Catalog Number
- A000435
- Company Name
- ATRICURE, INC.
- Labeler DUNS
- 006133784
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-11
- Public Version
- 1
- Public Version Date
- 2021-01-19
- Public Version Status
- New
- Public Device Record Key
- ffd3eb7c-c397-4f13-b10e-661c98dc70e8
Device Description
AtriCure Switch Box
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 35041 | Electrosurgical cable adaptor | A small connector used to join the cable(s) from a handpiece/electrode(s) (active and/or return) to the generator of an electrosurgical system. This device will typically be used when the system components are from different manufacturers and the connections are not compatible. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30840143903018 | GS1 | box | 1 | In Commercial Distribution | |
| Primary | 10840143901584 | GS1 | ||||
| Previous | 00818354010596 | 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 |
| P100046 | 011 |
| P100046 | 012 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -35 – 54 Degrees Celsius