FDA UDI
Not in Commercial Distribution
🇺🇸 United States
HEATfx 2.1 15cm Needle
DI: 07290104831157
·
Model: FPRPR5102
·
GALIL MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HEATfx 2.1 15cm Needle
- Primary DI
- 07290104831157
- Version / Model
- FPRPR5102
- Catalog Number
- FPRPR5102
- Company Name
- GALIL MEDICAL INC.
- Labeler DUNS
- 809529469
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-14
- Public Version
- 4
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- b2e76b8f-0db3-487e-9f48-654d31bf6d27
- Distribution End Date
- 2020-08-14
Device Description
Microwave ablation needle
Device Characteristics
- Single Use
- Yes
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NEY | System, Ablation, Microwave And Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61286 | Microwave ablation system probe, non-powered | A non-active, hand-held surgical instrument designed to connect to a microwave ablation system generator to deliver microwaves to a targeted operative site for localized soft-tissue ablation, typically to treat tumours, hydatid cysts and/or menorrhagia. The probe includes a handle and a patient contact region (e.g., antenna, leaflets), and might include a cooling mechanism (via water irrigation). The device is intended to be used in percutaneous, endoscopic [e.g., gastroscopic, laparoscopic], natural orifice or open surgery procedures to ablate tissues (e.g., endometrial ablation). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290104831157 | GS1 |
Customer Contacts
- Phone
- 651-287-5000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Shaft diameter: 2.1mm | ||
| Device Size Text, specify | Shaft Length: 15cm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Cool, dry place