FDA UDI
In Commercial Distribution
🇺🇸 United States
nGEN Generator
DI: 10846835018080
·
Model: D138402
·
Biosense Webster Inc
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- nGEN Generator
- Primary DI
- 10846835018080
- Version / Model
- D138402
- Catalog Number
- D138402
- Company Name
- Biosense Webster Inc
- Labeler DUNS
- 020163218
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-18
- Public Version
- 1
- Public Version Date
- 2022-08-26
- Public Version Status
- New
- Public Device Record Key
- 7bf94063-b51e-42ac-80ea-c024d889d3e1
Device Description
Generator
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 |
|---|---|---|---|---|
| OAE | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation | Unknown | 3 | |
| DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | Cardiovascular | 870.1220 | 2 |
| OAD | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | Unknown | 3 | |
| LBP | REPLACEMENT, OSSICULAR (STAPES) USING ABSORBABLE GELATIN MATERIAL | Ear, Nose, Throat | 874.3450 | 2 |
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 | 10846835018080 | GS1 |
Customer Contacts
- Phone
- +1(800)729-9010
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P010068 | 067 |
| P030031 | 122 |
| P040036 | 084 |
| P950005 | 082 |
| P990025 | 067 |
| P990071 | 051 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight