FDA UDI
In Commercial Distribution
🇺🇸 United States
NEUWAVE
DI: 10818913020698
·
Model: PRS35
·
NEUWAVE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- NEUWAVE
- Primary DI
- 10818913020698
- Version / Model
- PRS35
- Catalog Number
- PRS35
- Company Name
- NEUWAVE MEDICAL, INC.
- Labeler DUNS
- 809758878
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-14
- Public Version
- 1
- Public Version Date
- 2024-06-24
- Public Version Status
- New
- Public Device Record Key
- 1358d5f6-c1c6-4a27-b807-02d6fa5c5ca9
Device Description
NW SURGICAL PR PROBE 35CM 11GA
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
- 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 |
|---|---|---|---|---|---|---|
| Package | 20818913020695 | GS1 | BOX | 5 | In Commercial Distribution | |
| Primary | 10818913020698 | GS1 |
Customer Contacts
- Phone
- +1(877)384-4266
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231738 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- High: 30 Degrees Celsius