AccuPlan/AccuPlate
- Primary DI
- 00810007631301
- Brand
- AccuPlan/AccuPlate
- Company
- Medcad
- Model
- ZB-KP210
- Catalog number
- ZB-KP210
- Device description
- MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE, NO GUIDES
- Published
- 2023-06-23
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| JEY | Plate, Bone | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00810007631301 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00810007631301 | 00810007631301 | 810007631301 | 0810007631301 |
GMDN Terms
| Term | Definition |
|---|
| Custom-made organ/bone anatomy model/surgical guide kit | A collection of custom-made devices intended to be used to assist anatomical visualization, surgical treatment planning, and intraoperative surgical procedures (e.g., orientation of implant components, guiding of surgical instruments). It consists of an anatomy model(s) of an organ/bone and an orthopaedic/craniomaxillofacial surgical guide(s) [e.g., for osteotomy, arthroplasty]; it is made of synthetic polymer materials and is manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device intended to be sterilized prior to use. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 144723868
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- 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
- true
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00888118149671 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149701 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149718 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149725 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149732 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149749 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149756 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149763 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149770 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149787 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149794 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149800 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149817 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149824 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149831 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149848 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149855 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149879 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149886 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149893 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149909 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149916 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149923 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149930 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149947 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149954 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149961 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149978 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118149985 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
| 00888118153128 | LEVEL ONE NEURO, STERILE | KLS-Martin L.P. | JEY | 2026-03-23 |
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