mahe medical GmbH
- Primary DI
- 04050659518179
- Brand
- mahe medical GmbH
- Company
- mahe medical gmbh
- Model
- PSS10-6525
- Device description
- Polyaxial screw, w/o cannulation, _x000D_6.5mm/25mm _x000D_
- Published
- 2019-11-05
- 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 |
|---|---|
| NKB | Thoracolumbosacral pedicle screw system |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04050659518179 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04050659518179 | 04050659518179 | 4050659518179 |
GMDN Terms
| Term | Definition |
|---|---|
| Bone-screw internal spinal fixation system, non-sterile | An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 342243334
- 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
- true
- 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 |
|---|---|---|---|---|
| 04050659161702 | mahe medical GmbH | 001-0001-006S | 2019-11-05 | |
| 04050659161719 | mahe medical GmbH | 001-0001-006ST | 2019-11-05 | |
| 04050659161726 | mahe medical GmbH | 001-0001-006XS | 2019-11-05 | |
| 04050659161740 | mahe medical GmbH | 001-0001-007S | 2019-11-05 | |
| 04050659161757 | mahe medical GmbH | 001-0001-007ST | 2019-11-05 | |
| 04050659161764 | mahe medical GmbH | 001-0001-007XS | 2019-11-05 | |
| 04050659161801 | mahe medical GmbH | 001-0001-008XS | 2019-11-05 | |
| 04050659161825 | mahe medical GmbH | 001-0001-009S | 2019-11-05 | |
| 04050659161849 | mahe medical GmbH | 001-0001-009XS | 2019-11-05 | |
| 04050659161863 | mahe medical GmbH | 001-0001-010S | 2019-11-05 | |
| 04050659161887 | mahe medical GmbH | 001-0001-010XS | 2019-11-05 | |
| 04050659161948 | mahe medical GmbH | 001-0001-012S | 2019-11-05 | |
| 04050659161962 | mahe medical GmbH | 001-0001-012XS | 2019-11-05 | |
| 04050659162013 | mahe medical GmbH | 001-0001-014S | 2019-11-05 | |
| 04050659162037 | mahe medical GmbH | 001-0001-014XS | 2019-11-05 | |
| 04050659162051 | mahe medical GmbH | 001-0001-016S | 2019-11-05 | |
| 04050659162068 | mahe medical GmbH | 001-0001-016ST | 2019-11-05 | |
| 04050659162075 | mahe medical GmbH | 001-0001-016XS | 2019-11-05 | |
| 04050659162112 | mahe medical GmbH | 001-0001-018XS | 2019-11-05 | |
| 04050659162150 | mahe medical GmbH | 001-0001-020XS | 2019-11-05 |
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| 00840185382573 | 4CIS WILL PEDICLE SCREW SYSTEM | SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED | NKB | 2026-05-25 |
| 00840185382580 | 4CIS WILL PEDICLE SCREW SYSTEM | SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED | NKB | 2026-05-25 |
| 00840185382597 | 4CIS WILL PEDICLE SCREW SYSTEM | SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED | NKB | 2026-05-25 |
| 07290014381254 | ProMIS™ Fixation System | PREMIA SPINE LTD | NKB | 2026-05-25 |
| 07290014381261 | ProMIS™ Fixation System | PREMIA SPINE LTD | NKB | 2026-05-25 |
| 07290115935615 | Counter Torque ST | PREMIA SPINE LTD | NKB | 2026-05-25 |
| 06941312465757 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465764 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465771 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465788 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465795 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465801 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465818 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465825 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465832 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465849 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465856 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465887 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465894 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465900 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465559 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465566 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465573 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465580 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465597 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465603 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465610 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465627 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465634 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |