FDA UDI
In Commercial Distribution
🇺🇸 United States
Arion Easy-Off
DI: 08717127941247
·
Model: Made-to-measure
·
Arion Holding B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Arion Easy-Off
- Primary DI
- 08717127941247
- 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
- 2023-11-03
- Public Version
- 1
- Public Version Date
- 2023-11-13
- Public Version Status
- New
- Public Device Record Key
- d1b070fb-be8c-414d-98d6-fb198612787d
Device Description
Application aid (donning and doffing) for medical compression garments
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 |
|---|---|---|---|---|
| 66053 | Compression/pressure sock/stocking applicator | A flexible plastic device intended to be used to assist in the application of a compression/pressure sock/stocking, or arm sleeve, onto a patient’s limb. The sock/stocking is typically rolled over the limb-applied device which is pulled to advance the sock/stocking over the limb. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717127941247 | GS1 |