FDA UDI
In Commercial Distribution
🇺🇸 United States
InMode RF hand piece
DI: 07290016633481
·
Model: HP060909A
·
INMODE M.D LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- InMode RF hand piece
- Primary DI
- 07290016633481
- Version / Model
- HP060909A
- Catalog Number
- HP060909A
- Company Name
- INMODE M.D LTD
- Labeler DUNS
- 600417351
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-04
- Public Version
- 1
- Public Version Date
- 2022-12-12
- Public Version Status
- New
- Public Device Record Key
- b94ace0d-b0cb-4140-94d6-fb5e3756f18c
Device Description
AccuTite
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48005 | Radio-frequency fat liquefaction system | An assembly of devices using radio-frequency (RF) energy for simultaneous adipose tissue liquefaction, blood vessel coagulation, and skin tightening during a radio-frequency-assisted liposuction (RFAL) procedure [lipectomy], typically performed for body contouring. The system consists of an RF-generating control unit that supplies RF energy to a dedicated applicator (handpiece) and provides continuous tissue temperature monitoring; impedance and power monitoring with tissue overheating safety systems; the RF applicator; and a foot-switch to control the RF energy supply. The liquified tissue is aspirated with an independent external suction system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290016633481 | GS1 |
Customer Contacts
- Phone
- 1-887-367-4556
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182325 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 110 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 90 – 110 KiloPascal