FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 04055207069257
·
Model: 100698
·
Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 04055207069257
- Version / Model
- 100698
- Catalog Number
- 100698
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-12
- Public Version
- 1
- Public Version Date
- 2026-03-20
- Public Version Status
- New
- Public Device Record Key
- 769d2836-22e8-4de1-8a69-60d733d4ec62
Device Description
GEL PAD ASSORTMENT F10 G10 for use with the PiezoWave 2, penetration depth 10 mm, 20 mm, 30 mm, 40 mm, 50 mm and 60 mm
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| ISA | Massager, therapeutic, electric | Physical Medicine | 890.5660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47790 | Electromechanical orthopaedic extracorporeal shock wave therapy system | An assembly of devices designed to provide electromechanical orthopaedic extracorporeal shock wave therapy (OEST) to treat musculoskeletal disorders. It is typically portable and includes a control unit that uses an electrical current to create kinetic energy (e.g., with a coil gun) which is transferred to a patient's body upon contact (e.g., with a hand-held surface applicator) 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 | 04055207069257 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity