FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DigiTrainer
DI: 04260397621110
·
Model: DigiTrainer
·
HASOMED GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DigiTrainer
- Primary DI
- 04260397621110
- Version / Model
- DigiTrainer
- Catalog Number
- Hand0100
- Company Name
- HASOMED GmbH
- Labeler DUNS
- 341439008
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-01
- Public Version
- 3
- Public Version Date
- 2022-01-20
- Public Version Status
- Update
- Public Device Record Key
- 429d2aed-1d70-4144-8731-42d1559e045a
- Distribution End Date
- 2021-12-31
Device Description
Exerciser, Finger, Powered
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
- 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 |
|---|---|---|---|---|
| JFA | Exerciser, Finger, Powered | Physical Medicine | 890.5410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35538 | Large-area electric massager | An electrically-powered device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may utilize vibrating belts or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment. This device is intended for use in healthcare facilities and is not applicable to home therapies. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260397621110 | GS1 |