FDA UDI
In Commercial Distribution
🇺🇸 United States
Arion Proth-Pro
DI: 08717127934454
·
Model: Made-to-measure
·
Arion Holding B.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Arion Proth-Pro
- Primary DI
- 08717127934454
- Version / Model
- Made-to-measure
- Company Name
- Arion Holding B.V.
- Labeler DUNS
- 489495862
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-03
- Public Version
- 1
- Public Version Date
- 2025-02-11
- Public Version Status
- New
- Public Device Record Key
- 191bf52c-5cc0-4f50-88cc-668ac69a7adb
Device Description
Donning aid for transfemoral prostheses
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- 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 |
|---|---|---|---|---|
| IPM | Cover, Limb | Physical Medicine | 890.3025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31050 | Assistive sock/pantyhose dressing device | A device designed to assist a person with a disability to put on and take off their socks, stockings, and tights (pantyhose). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717127934454 | GS1 | ||||
| Previous | 08717127941285 | GS1 |