FDA UDI
In Commercial Distribution
🇺🇸 United States
Prolieve
DI: B0638808060
·
Model: Original
·
Medifocus, Inc.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Prolieve
- Primary DI
- B0638808060
- Version / Model
- Original
- Company Name
- Medifocus, Inc.
- Labeler DUNS
- 828790159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-09
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 38c9d4f2-7a30-4798-b33b-0b2de9572c5b
Device Description
Prolieve Thermodilatation System
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40783 | Microwave hyperthermia system | A mains electricity (AC-powered) device assembly designed for controlled heating (i.e., temperatures above 43° Celsius) of the body using microwaves, for the treatment of malignant or benign tumours or other disease conditions [e.g., benign prostatic hyperplasia (BPH), prostatitis]. It includes a microwave generator, controls, software (e.g., treatment planning software) and a microwave applicator. It is intended for both whole-body and localized heating of tissues/organs through either externally-mounted components or from catheter- or probe-type applicators inserted topically, endoscopically, or surgically. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B0638808060 | HIBCC |