ACTIVDAY
- Primary DI
- 05391512286019
- Brand
- ACTIVDAY
- Company
- INDACO SRL
- Model
- 500 4XL
- Catalog number
- 500
- Device description
- This ACTIVDAY Lumbar-Sacral Brace acts as an immobilizing device for the lumbar-sacral region and its’ primary function is to reduce pain caused by lumbago, sciatica and ischialgia. Made with semi-rigid fabric, it enjoys a structure made with eight self modeling and flexible steel stays on which a number of rigid straps slide. When the locking system is pulled and secured at the front, the inside straps stiffen the entire structure, thus effectively immobilizing the lumbar-sacral region. Two rigid thermo-formable panels for lumbar and abdominal application are included. These panels produce intra-abdominal pressure to reduce load on discs thus reducing pain and improving post-operative outcome when used with the corset in the appropriate position. The supported region extends from the sacrococcygeal joint to T-9 vertebra. Practical and easy to wear, this brace perfectly adapts to whatever size and body type, thus ensuring maximum support and comfort at the desired tension. Through a new locking technology, operated by means of two crossing bands, the closing system is totally user friendly and allows a wide range of elastic tension settings. INDICATIONS •Lumbago, sciatica and ischialgia.. •Lumbar-Sacral pain of other origin and nature. •Disc complaints. •Spondylo-arthrosis. •Osteoporosis related lumbar vertebrae complaints. •Para-vertebral lumbar muscle spasm. •Light trauma of the lumbar-sacral column.
- Published
- 2024-01-31
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- true
- Sterile
- false
- Single use
- false
Related Records
Contact Domains
Product Codes
| Code | Name |
|---|---|
| IPY | Orthosis, Lumbo-Sacral |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| IPY | Orthosis, Lumbo-Sacral | Physical Medicine | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05391512286019 | Package | GS1 | 10 | In Commercial Distribution |
| 05391512281212 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05391512286019 | 05391512286019 | 5391512286019 |
| 05391512281212 | 05391512281212 | 5391512281212 |
GMDN Terms
| Term | Definition |
|---|---|
| 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. |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| 1-866-374-4050 | contact@m-brace.com |
Regulatory Flags
- DUNS number
- 338470646
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|---|---|---|---|
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| 05391512282929 | HPH Corp. | 648K size 30 | 648K | 2024-04-04 |
| 05391512282936 | HPH Corp. | 648K size 32 | 648K | 2024-04-04 |
| 05391512282943 | HPH Corp. | 648K size 34 | 648K | 2024-04-04 |
| 05391512282950 | HPH Corp. | 648K size 36 | 648K | 2024-04-04 |
| 05391512282967 | HPH Corp. | 648K size 38 | 648K | 2024-04-04 |
| 05391512282974 | HPH Corp. | 648K size 40 | 648K | 2024-04-04 |
| 05391512282981 | HPH Corp. | 648K size 42 | 648K | 2024-04-04 |
| 05391512282998 | HPH Corp. | 648K size 44 | 648K | 2024-04-04 |
| 05391512283001 | HPH Corp. | 648K size 46 | 648K | 2024-04-04 |
| 05391512283018 | HPH Corp. | 648K size 48 | 648K | 2024-04-04 |
| 05391512283025 | HPH Corp. | 648K size 50 | 648K | 2024-04-04 |
| 05391512283032 | HPH Corp. | 648K size 52 | 648K | 2024-04-04 |
| 05391512283049 | HPH Corp. | 648K size 54 | 648K | 2024-04-04 |
| 05391512283056 | HPH Corp. | 648K size 56 | 648K | 2024-04-04 |
| 05391512283087 | HPH Corp. | 648K h12 size 26 | 648K h12 | 2024-04-04 |
| 05391512283094 | HPH Corp. | 648K h12 size 28 | 648K h12 | 2024-04-04 |
| 05391512283100 | HPH Corp. | 648K h12 size 30 | 648K h12 | 2024-04-04 |
| 05391512283117 | HPH Corp. | 648K h12 size 32 | 648K h12 | 2024-04-04 |
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| 05391512286026 | ACTIVDAY | INDACO SRL | IPY | 2024-02-09 |
| 05391512286033 | ACTIVDAY | INDACO SRL | IPY | 2024-02-09 |
| 05391512286057 | ACTIVDAY | INDACO SRL | IPY | 2024-02-09 |
| 05391512286064 | ACTIVDAY | INDACO SRL | IPY | 2024-02-09 |
| 05391512286095 | ACTIVDAY | INDACO SRL | IPY | 2024-02-09 |
| 05391512286101 | ACTIVDAY | INDACO SRL | IPY | 2024-02-09 |
| 05391512286118 | ACTIVDAY | INDACO SRL | IPY | 2024-02-09 |
| 05391512286125 | ACTIVDAY | INDACO SRL | IPY | 2024-02-09 |
| 05391512286132 | ACTIVDAY | INDACO SRL | IPY | 2024-02-09 |
| 05391512286149 | ACTIVDAY | INDACO SRL | IPY | 2024-02-09 |
| 05391512286156 | ACTIVDAY | INDACO SRL | IPY | 2024-02-09 |
| 05391512285951 | ACTIVDAY | INDACO SRL | IPY | 2024-01-31 |
| 05391512285968 | ACTIVDAY | INDACO SRL | IPY | 2024-01-31 |
| 05391512285975 | ACTIVDAY | INDACO SRL | IPY | 2024-01-31 |
| 05391512285982 | ACTIVDAY | INDACO SRL | IPY | 2024-01-31 |
| 05391512285999 | ACTIVDAY | INDACO SRL | IPY | 2024-01-31 |
| 05391512286002 | ACTIVDAY | INDACO SRL | IPY | 2024-01-31 |
| 05391512286040 | ACTIVDAY | INDACO SRL | IPY | 2024-01-31 |
| 05391512286071 | ACTIVDAY | INDACO SRL | IPY | 2024-01-31 |
| 05391512286088 | ACTIVDAY | INDACO SRL | IPY | 2024-01-31 |
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