FDA UDI
In Commercial Distribution
🇺🇸 United States
ENTire IRE System
DI: 07290119640003
·
Model: Generator
·
ENTIRE MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ENTire IRE System
- Primary DI
- 07290119640003
- Version / Model
- Generator
- Catalog Number
- ENTIRE001
- Company Name
- ENTIRE MEDICAL LTD
- Labeler DUNS
- 625930878
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-24
- Public Version
- 1
- Public Version Date
- 2026-03-04
- Public Version Status
- New
- Public Device Record Key
- a4e10b74-7105-4fab-b625-1f1fe6b66057
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
- Yes
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64224 | Irreversible electroporation system generator | A mains electricity (AC-powered) device designed to generate microsecond electrical pulses to produce irreversible cell membrane electroporation, a phenomenon that induces cell membrane pores to open resulting in loss of homeostasis and subsequent cell death. It includes controls (e.g., foot-switch) and user interface; additional system components necessary for the procedure [e.g., electrocardiogram (ECG) trigger monitor electrode probe/catheter] are not included. It is intended for the nonthermal surgical ablation of soft-tissues and may be intended for one or more clinical application(s). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290119640003 | GS1 |
Customer Contacts
- Phone
- 1-800-4080120
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251996 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius