FDA UDI
In Commercial Distribution
🇺🇸 United States
PLUS
DI: 05708590368917
·
Model: R391385
·
Pressalit A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PLUS
- Primary DI
- 05708590368917
- Version / Model
- R391385
- Catalog Number
- R391385112
- Company Name
- Pressalit A/S
- Labeler DUNS
- 305656662
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-08
- Public Version
- 1
- Public Version Date
- 2020-06-16
- Public Version Status
- New
- Public Device Record Key
- d3c495ec-e7bb-4adf-a922-3a0583aa7a6a
Device Description
PLUS support arm, 850 mm, anthracite. Height and sideways adjustable, left hand operated, for retro-fitting
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| ILS | Adaptor, Hygiene | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35585 | Toilet hand rail | A device of various bar-shaped designs intended to provide a person with a disability a supportive hand-hold when lowering or raising their body to or from the toilet. It may be designed to be wall-mounted or affixed to the toilet. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05708590368917 | GS1 |
Customer Contacts
- Phone
- +4587888788
- [email protected]