FDA UDI
In Commercial Distribution
🇺🇸 United States
Isolator Surgical Ablation System
DI: 30840143902950
·
Model: ASU2
·
ATRICURE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Isolator Surgical Ablation System
- Primary DI
- 30840143902950
- Version / Model
- ASU2
- Catalog Number
- A000019
- Company Name
- ATRICURE, INC.
- Labeler DUNS
- 006133784
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-06
- Public Version
- 1
- Public Version Date
- 2026-02-16
- Public Version Status
- New
- Public Device Record Key
- 9899ec49-5229-4b6e-922b-fcd0fc5f0266
Device Description
Ablation and Sensing Unit
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
- 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
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- High-level Disinfectant
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 | 10840143901553 | GS1 | ||||
| Primary | 30840143902950 | GS1 | ||||
| Previous | 00818354010206 | GS1 |
Customer Contacts
- Phone
- 866-449-2342
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P100046 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -45 – 54 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity