FDA UDI
In Commercial Distribution
🇺🇸 United States
Emprint HP
DI: 10884521781276
·
Model: CAGENHP
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Emprint HP
- Primary DI
- 10884521781276
- Version / Model
- CAGENHP
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-24
- Public Version
- 4
- Public Version Date
- 2022-09-30
- Public Version Status
- Update
- Public Device Record Key
- bd2e9e73-b797-4793-abc1-80c766887f63
Device Description
Ablation Generator with Thermosphere Technology 150W
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
- 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
- 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 |
|---|---|---|---|---|
| NEY | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES | General, Plastic Surgery | 878.4400 | 2 |
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 | 10884521781276 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200796 | 000 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -22 – 140 Degrees Fahrenheit