BunionETTE Bootie
- Primary DI
- 04518227055636
- Brand
- BunionETTE Bootie
- Company
- SLO LIVING LLC
- Model
- MediumRight
- Device description
- Soft, ultra-thin, flexible orthotic for bunions (hallux valgus) and bunionettes (tailor's bunion). The full coverage toe hood covers the big toe and is secured with a heel strap.
- Published
- 2020-08-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| ILG | Stocking, Elastic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ILG | Stocking, Elastic | Physical Medicine | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 04518227055636 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 04518227055636 | 04518227055636 | 4518227055636 |
GMDN Terms
| Term | Definition |
|---|
| Hallux valgus metatarsophalangeal orthosis | A non-rigid device intended to be worn on the foot to help prevent and/or reduce hallux valgus deformity, thereby reducing walking pain and bunion formation. It is made of elastic fabric materials and may encompass only the metatarsophalangeal region or extend around the heel for tensioning. It is normally available [non-prescription] over-the-counter (OTC) for use in the home. This is a single-patient use device that can be reapplied by the patient during the treatment period (reusable) before being discarded. |
Regulatory Flags
- DUNS number
- 078436895
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- 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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| 00636257031452 | MEDI | MEDI MANUFACTURING, INC. | ILG | 2021-09-07 |
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