ACTIVDAY
Basic Information
- Brand Name
- ACTIVDAY
- Primary DI
- 05391512281250
- Version / Model
- 501 XL
- Catalog Number
- 501
- Company Name
- INDACO SRL
- Labeler DUNS
- 338470646
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-09
- Public Version
- 1
- Public Version Date
- 2024-02-19
- Public Version Status
- New
- Public Device Record Key
- f0fd257f-8a3f-4aed-88c1-e8270c972696
Device Description
The ACTIVDAY NO. 501 lumbar-sacral orthosis is designed to support the patient at all stages of his/her recovery. The moldable panels are to be applied post-op without delay for effective immobilization, and kept in place throughout the rehabilitation phase. Later the corset, worn alone, can be adapted to provide comfortable daily support thanks to the progressive immobilization capabilities of our patent pending locking system featuring inter-crossed steps and flexible plastic-covered steel stays. Combined with our comfortable and breathable knitted cotton fabric, you get a result that speaks for itself: Perfect patient compliance. ACTIVDAY NO. 501 consists of 3 separate pieces: A corset fitted with eight (8) flexible steel stays, a covered lumbar thermoplastic panel and an abdominal thermoplastic panel. Indications: • Supports from sacrum to T-9 level. • P ost-op: Following stabilizing surgery, following lumbar disk surgery. • D egenerative pathologies: Osteoporosis, lumbarsacral vertebrae complaint, protrusions, arthritis. • Muscular pathologies: Muscular contractures. • P ractical and easy to fit, it adapts perfectly to your body. • This corset acts as a corrective measure and as a support to postural defects. • Breathable and non allergenic, 100% cotton. • Front panel is 6 3/4” high.
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
- 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
- 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 |
|---|---|---|---|---|
| IPY | Orthosis, Lumbo-Sacral | Physical Medicine | 890.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33031 | Lumbar spine orthosis | A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05391512286057 | GS1 | Box Case | 10 | In Commercial Distribution | |
| Primary | 05391512281250 | GS1 |
Customer Contacts
- Phone
- 1-866-374-4050
- [email protected]