FDA UDI
In Commercial Distribution
🇺🇸 United States
Rolyan
DI: 00885914038659
·
Model: 081296003
·
Performance Health Supply, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Rolyan
- Primary DI
- 00885914038659
- Version / Model
- 081296003
- Company Name
- Performance Health Supply, LLC
- Labeler DUNS
- 966806150
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-04
- Public Version
- 1
- Public Version Date
- 2024-10-14
- Public Version Status
- New
- Public Device Record Key
- f299f05b-9132-4b26-8796-426849a85220
Device Description
Rolyan Scar Pump
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| LYG | Massager, Therapeutic, Manual | Physical Medicine | 890.5660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34009 | External manual massager, clinical | A manual (non-powered) device designed to apply external massage to a patient, by the patient, staff, or a therapist in a hospital, institution, or therapeutic treatment situation. It is intended to stimulate/massage body muscles to provide a therapeutic effect. It is typically designed to be held in the hands and is available in a variety of configurations and materials, e.g., plastic, wood, ceramics. It is available in a variety of sizes and shapes and may be a one-piece device or have interchangeable massaging components (e.g., roller heads or pads), and have a variety of massage surfaces (e.g., points, ribs, smooth). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00885914038659 | GS1 |