DARCO® Posterior Splint
- Primary DI
- 20609271245192
- Brand
- DARCO® Posterior Splint
- Company
- DARCO INTERNATIONAL, INC.
- Model
- PS1-90-P1
- Catalog number
- PS1-90-P1
- Device description
- S - 90° Plus White 90° Plus
- 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
Product Codes
| Code | Name |
|---|
| NOC | Splint, extremity, non-inflatable, external, non-sterile |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NOC | Splint, Extremity, Non-Inflatable, External, Non-Sterile | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10609271245195 | Package | GS1 | 4 | In Commercial Distribution |
| 20609271245192 | Package | GS1 | 12 | In Commercial Distribution |
| 00609271245198 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10609271245195 | 10609271245195 | | |
| 20609271245192 | 20609271245192 | | |
| 00609271245198 | 00609271245198 | 609271245198 | 0609271245198 |
GMDN Terms
| Term | Definition |
|---|
| Lower-limb orthosis ankle/foot component | A non-powered prefabricated (non-customized) component of an externally applied and wearable lower-limb appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct deformities/injuries (e.g., paralysis) or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It is intended to provide motion control functionality through a media-free mechanical resistance mechanism [i.e., spring-actuation with no fluid or gas operating media]. This is a reusable device. |
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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