FDA UDI
In Commercial Distribution
🇺🇸 United States
Orthospec
DI: 07290016498417
·
Model: OR-3-A999u
·
MEDISPEC LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Orthospec
- Primary DI
- 07290016498417
- Version / Model
- OR-3-A999u
- Company Name
- MEDISPEC LTD.
- Labeler DUNS
- 600300909
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-22
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 1ff08c82-3657-4495-9775-aa509907937e
Device Description
Orthospec is based on shock wave therapy method and is intended to apply shock waves to the heel tissue of patients who have Proximal Plantar Fasciitis and who have failed previous conservative therapies.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| NBN | Generator, Shock-Wave, For Pain Relief | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47789 | Spark-gap orthopaedic extracorporeal shock wave therapy system | A mobile assembly of devices designed to provide spark-gap-generated orthopaedic extracorporeal shock wave therapy (OEST) to treat musculoskeletal disorders. It typically consists of a generator with two submerged electrodes that produce spark-gap (electrohydraulic) energy, at selected impulse frequencies, transmitted in reflector-focused waves to a target area on the patient's body surface via a water-filled membrane (e.g., latex) held against the target area during treatment. It is used to treat disorders such as patellar tendonitis, soft tissue pain near bones, plantar fasciitis (heel pain), epicondylopathy (tennis elbow), and/or non-union fractures of bones. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290016498417 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P040026 | 000 |