DIPLOMAT
- Primary DI
- 04047844043783
- Brand
- DIPLOMAT
- Company
- SIGNUS Medizintechnik GmbH
- Model
- Reamer
- Catalog number
- AC0071-Z2
- Device description
- An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
- Published
- 2022-06-09
- 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
- false
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| LYS | Bone Mill | Orthopedic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 04047844043783 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 04047844043783 | 04047844043783 | 4047844043783 |
GMDN Terms
| Term | Definition |
|---|
| Orthopaedic surgical procedure kit, non-medicated, reusable | A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 0 Degrees Celsius | 35 Degrees Celsius | |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | Email |
|---|
| +49602391660 | info@signus.com |
Regulatory Flags
- DUNS number
- 344203948
- 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
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 04047844129272 | INSTRUMENT | Tray, instruments | P009AY | 2026-02-11 |
| 04047844129289 | INSTRUMENT | Tray, insert, instruments | P009AZ | 2026-02-11 |
| 04047844129296 | COSY | Tray, implants | CA01AY | 2026-02-11 |
| 04047844129302 | COSY | Tray, insert, implants | CA01AZ | 2026-02-11 |
| 04047844129319 | COSY | Tray, implants | CA02AY | 2026-02-11 |
| 04047844129326 | COSY | Rack, screws | CA1235AZ | 2026-02-11 |
| 04047844129333 | COSY | Rack, screws | CA1240AZ | 2026-02-11 |
| 04047844129340 | COSY | Rack, screws | CA1245AZ | 2026-02-11 |
| 04047844129357 | COSY | Rack, shank screws | CA1735AZ | 2026-02-11 |
| 04047844129364 | COSY | Rack, shank screws | CA1740AZ | 2026-02-11 |
| 04047844129371 | COSY | Rack, screws angled | CA3235AZ | 2026-02-11 |
| 04047844129388 | COSY | Rack, screws angled | CA3240AZ | 2026-02-11 |
| 04047844129395 | COSY | Rack, set screws | CA0140AZ | 2026-02-11 |
| 04047844129401 | COSY | Rack, set screws, connectors | CA0150AZ | 2026-02-11 |
| 04047844130124 | INSTRUMENT | Lamina Spreader | SN0027 | 2026-01-19 |
| 04047844122860 | CYLOX ST 12° | Cervical cage integrated, stand alone, angled | CYS12061512 | 2025-09-11 |
| 04047844122877 | CYLOX ST 12° | Cervical cage integrated, stand alone, angled | CYS12071512 | 2025-09-11 |
| 04047844122884 | CYLOX ST 12° | Cervical cage integrated, stand alone, angled | CYS12081512 | 2025-09-11 |
| 04047844122891 | CYLOX ST 12° | Cervical cage integrated, stand alone, angled | CYS12091512 | 2025-09-11 |
| 04047844122907 | CYLOX ST 12° | Cervical cage integrated, stand alone, angled | CYS12101512 | 2025-09-11 |
Other Devices Sharing Product Codes
signus.com