MECRON Elbow Splint Pediatric
- Primary DI
- 24251853900508
- Brand
- MECRON Elbow Splint Pediatric
- Company
- DARCO INTERNATIONAL, INC.
- Model
- OS030001
- Catalog number
- OS030001
- Device description
- XS Blue-Orange
- Published
- 2023-02-08
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| IOY | SUPPORT, ARM |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| IOY | Support, Arm | Physical Medicine | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 14251853900501 | Package | GS1 | 12 | In Commercial Distribution |
| 24251853900508 | Package | GS1 | 36 | In Commercial Distribution |
| 04251853900504 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 14251853900501 | 14251853900501 | |
| 24251853900508 | 24251853900508 | |
| 04251853900504 | 04251853900504 | 4251853900504 |
GMDN Terms
| Term | Definition |
|---|---|
| Elbow orthosis | A prefabricated (non-customized) externally applied and wearable orthopaedic appliance designed to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow. This is a reusable device. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 184231298
- 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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| 20609271989706 | Aircore™ Insole | ACIP115 | 2026-01-07 | |
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