FDA UDI
In Commercial Distribution
🇺🇸 United States
Accelstim
DI: 08050040997299
·
Model: UBHS-02
·
IGEA SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Accelstim
- Primary DI
- 08050040997299
- Version / Model
- UBHS-02
- Catalog Number
- 654300-9001
- Company Name
- IGEA SPA
- Labeler DUNS
- 429342710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-30
- Public Version
- 1
- Public Version Date
- 2022-09-07
- Public Version Status
- New
- Public Device Record Key
- dc93e8ed-0421-45ae-b130-72b561517b40
Device Description
Replacement Ultrasound Gel, Accelstim 4300
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LOF | Stimulator, Bone Growth, Non-Invasive | Orthopedic | 890.5870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18154 | Bone growth ultrasonic stimulator | A mains electricity (AC-powered) device designed to accelerate bone formation (osteogenesis) through the application of ultrasound energy. It typically consists of a pulsed low-intensity ultrasound generator that includes a transducer probe and a retaining and alignment fixture for the probe. The device is typically used to promote healing of nonunion fractures; it is also used to speed the healing of fresh fractures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08050040997299 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P210035 | 000 |