FDA UDI
In Commercial Distribution
🇺🇸 United States
Multifunctional Ablation Generator
DI: 30840143904473
·
Model: MAG
·
ATRICURE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Multifunctional Ablation Generator
- Primary DI
- 30840143904473
- Version / Model
- MAG
- Catalog Number
- A001372
- Company Name
- ATRICURE, INC.
- Labeler DUNS
- 006133784
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-21
- Public Version
- 2
- Public Version Date
- 2023-05-29
- Public Version Status
- Update
- Public Device Record Key
- 6e5799c0-7436-48a2-b591-ffd6e213b6f5
Device Description
The MAG is an electro-mechanical ablation system that utilizes both monopolar and bipolar radio frequency (RF) energy to ablate biological tissue. The MAG can be used with a variety of AtriCure Handpieces to perform cardiac ablations.
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Direct Marking | 10840143900044 | GS1 | ||||
| Primary | 30840143904473 | GS1 |
Customer Contacts
- Phone
- 866-449-2342
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221358 | 000 |
| P100046 | 013 |
| P100046 | 016 |
| P200002 | 004 |
| P200002 | 005 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Transit Temperature between -29 to 60 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Transit Humidity between 30% to 85% relative humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity