S5M
- Primary DI
- 03760177041950
- Brand
- S5M
- Company
- TEKNIMED
- Model
- T060407
- Catalog number
- T060407
- Published
- 2020-09-25
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| JDZ | Mixer, Cement, For Clinical Use |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| JDZ | Mixer, Cement, For Clinical Use | Orthopedic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 03760177041950 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 03760177041950 | 03760177041950 | 3760177041950 |
GMDN Terms
| Term | Definition |
|---|---|
| Orthopaedic cement preparation/delivery kit | A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 764746723
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 03701505801204 | Dynamo | Spinal Cement – MV | 11-5920 | 2026-02-02 |
| 03701505801211 | Dynamo | Spinal Cement System Syringe MV 1.5cc | 11-5921 | 2026-02-02 |
| 03701505801228 | Dynamo | Spinal Cement System Syringe MV 4cc | 11-5922 | 2026-02-02 |
| 03701505801235 | Dynamo | Spinal Cement System Gun MV | 11-5923 | 2026-02-02 |
| 03760177044326 | Signature -x Cement | SV | P/N191-14-4000 | 2026-01-23 |
| 03760177044333 | Signature -x Cement | LV | P/N191-14-4001 | 2026-01-23 |
| 03760177044340 | Signature -x Cement | MV | MVP/N191-14-4002 | 2026-01-23 |
| 03760177040090 | GENTAFIX | 1 | T040140G | 2025-09-02 |
| 03760177040137 | GENTAFIX | 3 | T040340G | 2025-09-02 |
| 03760177043176 | GENTAFIX | 3 MV | T040341G | 2025-09-02 |
| 03701505801020 | PureKit Syringe 1.5cc MV | T060428MV | 2025-03-31 | |
| 03701505801037 | META+ System 1.5cc MV | T040352MV | 2025-03-31 | |
| 03701505801075 | PUREKIT Syringes | T060426 | 2025-03-31 | |
| 03701505801082 | Syringes 4cc | T060427 | 2025-03-31 | |
| 03701505801099 | Syringes 1.5cc | T060428 | 2025-03-31 | |
| 03760177045361 | PureKit Gun MV | T060425MV | 2023-03-30 | |
| 03760177040113 | OPACITY + | T040320Z | T040320Z | 2015-10-16 |
| 03760177041110 | F20 | T040520 | T040520 | 2015-10-16 |
| 03760177041721 | HIGH V+ | T040321 | T040321 | 2017-08-22 |
| 03760177042391 | EXOFIX | T040323 | T040323 | 2015-10-16 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 04250203943482 | QuattroMix | Joline GmbH & Co. KG | JDZ | 2026-03-03 |
| 25060238201920 | Vacuum Cement Mixing Bowl | SUMMIT MEDICAL LIMITED | JDZ | 2025-11-18 |
| 25060238201722 | Quick-Vac® Vacuum Mixing Bowl | SUMMIT MEDICAL LIMITED | JDZ | 2025-01-10 |
| 25060238201739 | Quick-Vac® Vacuum Mixing Bowl | SUMMIT MEDICAL LIMITED | JDZ | 2025-01-10 |
| 25060238201746 | HiVac Bowl | SUMMIT MEDICAL LIMITED | JDZ | 2025-01-10 |
| 25060238201753 | Rally™ Vacuum Mixing Bowl | SUMMIT MEDICAL LIMITED | JDZ | 2025-01-10 |
| 25060238201784 | MiniMix™ | SUMMIT MEDICAL LIMITED | JDZ | 2025-01-10 |
| 25060238201791 | MiniMix™ LV | SUMMIT MEDICAL LIMITED | JDZ | 2025-01-10 |
| 25060238201883 | Mixing bowl, Spatula | SUMMIT MEDICAL LIMITED | JDZ | 2025-01-10 |
| 07613327545258 | AutoPlex VertaPlex | STRYKER CORPORATION | JDZ | 2024-11-21 |
| 07613327547535 | AutoPlex M4 | STRYKER CORPORATION | JDZ | 2024-11-21 |
| 08058964723758 | Disp. Mixing Bowl-O | G21 SRL | JDZ | 2024-10-14 |
| 08058964728654 | Arthrex Bone Cement Mixing Syringe | G21 SRL | JDZ | 2024-10-14 |
| 08058964728715 | Arthrex Bone Cement Open Mixing Bowl | G21 SRL | JDZ | 2024-10-14 |
| 08058964728753 | Arthrex Bone Cement Closed Mixing Bowl | G21 SRL | JDZ | 2024-10-14 |
| 08058964729057 | Arthrex Bone Cement Closed Mixing Bowl | G21 SRL | JDZ | 2024-10-14 |
| 08058964729064 | Arthrex Bone Cement Mixing Syringe | G21 SRL | JDZ | 2024-10-14 |
| 08058964724564 | PicoMix V | G21 SRL | JDZ | 2024-10-10 |
| 08058964724670 | PicoMix Bowl | G21 SRL | JDZ | 2024-10-10 |
| 08058964725042 | PicoMix Syringe | G21 SRL | JDZ | 2024-10-10 |
| 08058964726261 | PicoMix Syringe | G21 SRL | JDZ | 2024-10-10 |
| 08058964727831 | PicoMix Bowl | G21 SRL | JDZ | 2024-10-10 |
| 08058964727848 | PicoMix Syringe | G21 SRL | JDZ | 2024-10-10 |
| 06951233721610 | CLEANEST | Guangzhou Clean Medical Products Manufacturing Corp. | JDZ | 2024-05-15 |
| 06951233721634 | CLEANEST | Guangzhou Clean Medical Products Manufacturing Corp. | JDZ | 2024-05-15 |
| 06951233721658 | CLEANEST | Guangzhou Clean Medical Products Manufacturing Corp. | JDZ | 2024-05-15 |
| 06951233721665 | CLEANEST | Guangzhou Clean Medical Products Manufacturing Corp. | JDZ | 2024-05-15 |
| 06951233721672 | CLEANEST | Guangzhou Clean Medical Products Manufacturing Corp. | JDZ | 2024-05-15 |
| 06951233721696 | CLEANEST | Guangzhou Clean Medical Products Manufacturing Corp. | JDZ | 2024-05-15 |
| 06951233721719 | CLEANEST | Guangzhou Clean Medical Products Manufacturing Corp. | JDZ | 2024-05-15 |