FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Certus® 140
DI: 00853719006180
·
Model: 2.45 GHz Ablation System
·
NEUWAVE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Certus® 140
- Primary DI
- 00853719006180
- Version / Model
- 2.45 GHz Ablation System
- Catalog Number
- DR-000783
- Company Name
- NEUWAVE MEDICAL, INC.
- Labeler DUNS
- 809758878
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-18
- Public Version
- 4
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 0629e7fb-9862-4edb-ab2b-eb8d93f08aaf
- Distribution End Date
- 2021-04-30
Device Description
NEUWAVE AC System - 120V
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| JAK | System, x-ray, tomography, computed | Radiology | 892.1750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61287 | Microwave ablation system generator | A mains electricity (AC-powered) device intended to generate microwave energy for localized non-vascular soft-tissue ablation, typically to treat tumours, hydatid cysts and/or menorrhagia. The generator connects via a delivery cable to a probe (not included) for delivery of microwaves to the target tissues. It is intended to be used in percutaneous, laparoscopic, natural orifice or open surgery procedures to ablate tissue typically in the liver, lung, pancreas, kidney, and uterus (e.g., endometrial ablation). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853719006180 | GS1 |
Customer Contacts
- Phone
- +1(877)323-9283
- [email protected]
Storage Conditions
- 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
- Type
- Handling Environment Temperature
- Temperature Range
- -22 – 60 Degrees Celsius