FDA UDI
In Commercial Distribution
🇺🇸 United States
ZShape
DI: 04053815086369
·
Model: RFG-01
·
Zimmer MedizinSysteme GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ZShape
- Primary DI
- 04053815086369
- Version / Model
- RFG-01
- Catalog Number
- 5570
- Company Name
- Zimmer MedizinSysteme GmbH
- Labeler DUNS
- 316111251
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-19
- Public Version
- 1
- Public Version Date
- 2024-07-29
- Public Version Status
- New
- Public Device Record Key
- 5c904cb4-d2ac-4832-8f47-3b2f14768986
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 |
|---|---|---|---|---|
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66689 | Radio-frequency physical therapy system | An assembly of devices designed to produce and noninvasively transmit radio-frequency (RF) electromagnetic (EM) energy for localized treatment of a variety of soft-tissue, neuromuscular, and musculoskeletal injuries/disorders (e.g., joint pain/inflammation, stiffness, soft tissue injuries, muscle atrophy, muscle spasms) and improvement of localized blood circulation. It is intended for use in a clinical setting and typically consists of an electrically-powered, radio-frequency (RF) generator and an applicator/handpiece designed for transcutaneous RF energy application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04053815086369 | GS1 |
Customer Contacts
- Phone
- (800) 327-3576
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240178 | 000 |