FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DUOLITH®
DI: 07630039101336
·
Model: SD1 Tower
·
Storz Medical AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DUOLITH®
- Primary DI
- 07630039101336
- Version / Model
- SD1 Tower
- Company Name
- Storz Medical AG
- Labeler DUNS
- 481967776
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-23
- Public Version
- 2
- Public Version Date
- 2023-04-13
- Public Version Status
- Update
- Public Device Record Key
- b9bce044-f86d-4884-b570-5c48cb6e7060
- Distribution End Date
- 2021-06-29
Device Description
The device is indicated for extracorporeal shock wave treatment.
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| 47995 | Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system | An assembly of devices designed to provide electromechanical orthopaedic extracorporeal shock wave therapy (OEST) and pneumatic pressure wave therapy to treat musculoskeletal disorders. It is typically mobile and includes a control unit that uses both an electrical current and compressed air to create kinetic energy which is transferred to a patient's body upon contact (e.g., with two different hand-held surface applicators) to produce mechanical shock waves at selected amplitudes and frequencies. It is used to treat soft-tissue pain and inflammation near bones, disorders such as tendinopathies and lateral/medial epicondylitis, and to stimulate osteogenesis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07630039101336 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P080028 | 001 |