FDA UDI
In Commercial Distribution
🇺🇸 United States
NEUWAVE
DI: 00853719006401
·
Model: PR15XT
·
NEUWAVE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NEUWAVE
- Primary DI
- 00853719006401
- Version / Model
- PR15XT
- Catalog Number
- PR15XT
- Company Name
- NEUWAVE MEDICAL, INC.
- Labeler DUNS
- 809758878
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-13
- Public Version
- 6
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 4e4905bb-08ff-4d53-a052-51a502ee4938
Device Description
NEUWAVE PR XT Probe 15CM 15ga
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 | 00853719006401 | GS1 | ||||
| Package | 10853719006408 | GS1 | BOX | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(877)323-9283
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -22 – 60 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if package is damaged