FDA UDI
In Commercial Distribution
🇺🇸 United States
Swiss DolorClast
DI: 07613353077464
·
Model: FT-183#A/001
·
E.M.S. Electro Medical Systems S.A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Swiss DolorClast
- Primary DI
- 07613353077464
- Version / Model
- FT-183#A/001
- Company Name
- E.M.S. Electro Medical Systems S.A.
- Labeler DUNS
- 481233849
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-22
- Public Version
- 2
- Public Version Date
- 2018-09-03
- Public Version Status
- Update
- Public Device Record Key
- 09a0aebf-4fcf-4653-a289-b666bc9e9fea
Device Description
Swiss DolorClast
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
- 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 |
|---|---|---|---|---|
| 47032 | Pneumatic orthopaedic extracorporeal shock wave therapy system | An assembly of devices designed to provide pneumatic orthopaedic extracorporeal shock wave therapy (OEST) to treat musculoskeletal disorders. It typically consists of a control unit that produces pneumatically-generated shock waves at selected impulse frequencies, and a hand-held surface applicator used to apply the energy to the site of pain. It is commonly used to treat disorders such as tendinopathies (e.g., rotator cuff, patellar, Achilles), soft tissue pain near bones, plantar fasciitis (heel pain), epicondylopathy (tennis elbow), shin splints, and muscle-related pain syndromes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613353077464 | GS1 |
Customer Contacts
- Phone
- +41229944700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P050004 | 001 |