FDA UDI
In Commercial Distribution
🇺🇸 United States
ActaStim-S
DI: 00850372007264
·
Model: 1101-0001-R
·
THERAGEN, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ActaStim-S
- Primary DI
- 00850372007264
- Version / Model
- 1101-0001-R
- Catalog Number
- 1101-0001-R
- Company Name
- THERAGEN, LLC
- Labeler DUNS
- 080028759
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-08
- Public Version
- 1
- Public Version Date
- 2021-02-16
- Public Version Status
- New
- Public Device Record Key
- 68b725c7-8b5d-4b70-8d3a-6a2862ed309e
Device Description
ActaStim-S Spine Fusion Stimulator Replacement Generator
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
- Yes
- 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 |
|---|---|---|---|---|
| LOF | Stimulator, Bone Growth, Non-Invasive | Orthopedic | 890.5870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35463 | Patient-worn bone growth electromagnetic stimulator | A battery-powered, body-worn device designed to apply an electrical stimulus directly to bone to promote bone formation (i.e., osteogenesis). It is intended to generate an electromagnetic (EM) field (and its associated induced voltage effects) around a fracture or fusion site; it is not intended to apply an electric current directly to the body. The device is used as an alternative to bone grafting for non-union fractures (a condition in which the ends of a fractured bone fail to unite), and as a spinal fusion adjunct in treating degenerative vertebral diseases. It is also known as an osteogenesis stimulator. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850372007264 | GS1 |
Customer Contacts
- Phone
- 1-800-901-5667
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P190030 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 700 – 1060 millibar
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 700 – 1060 millibar