MegaCerfix Anterior Cervical Plate System
- Primary DI
- 00840273301585
- Brand
- MegaCerfix Anterior Cervical Plate System
- Company
- Aegis Spine, Inc.
- Model
- CP02-0602-AU
- Catalog number
- CP02-0602-AU
- Device description
- Lock Driver - Gen1
- Published
- 2021-09-14
- 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
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| LXH | Orthopedic Manual Surgical Instrument |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00840273301585 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00840273301585 | 00840273301585 | 840273301585 | 0840273301585 |
GMDN Terms
| Term | Definition |
|---|---|
| General internal orthopaedic fixation system implantation kit | A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Dry Heat Sterilization |
Regulatory Flags
- DUNS number
- 017993061
- 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
- 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
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|---|---|---|---|---|
| 00840273320937 | Paeon Anterior Cervical Plate System | 6712-1731 | 6712-1731 | 2023-01-30 |
| 00840273320944 | Paeon Anterior Cervical Plate System | 6712-1733 | 6712-1733 | 2023-01-30 |
| 00840273320951 | Paeon Anterior Cervical Plate System | 6713-1742 | 6713-1742 | 2023-01-30 |
| 00840273320968 | Paeon Anterior Cervical Plate System | 6713-1745 | 6713-1745 | 2023-01-30 |
| 00840273320975 | Elatus Lumbar Plate System | 5015-1426 | 5015-1426 | 2023-01-30 |
| 00840273320982 | Elatus Lumbar Plate System | 5015-1527 | 5015-1527 | 2023-01-30 |
| 00840273320999 | Elatus Lumbar Plate System | 5015-1628 | 5015-1628 | 2023-01-30 |
| 00840273321002 | Elatus Lumbar Plate System | 5015-1830 | 5015-1830 | 2023-01-30 |
| 00840273321286 | Paeon Anterior Cervical Plate System | 6712-1731S | 6712-1731S | 2023-01-30 |
| 00840273321293 | Paeon Anterior Cervical Plate System | 6712-1733S | 6712-1733S | 2023-01-30 |
| 00840273321309 | Paeon Anterior Cervical Plate System | 6713-1742S | 6713-1742S | 2023-01-30 |
| 00840273321316 | Paeon Anterior Cervical Plate System | 6713-1745S | 6713-1745S | 2023-01-30 |
| 00840273321323 | Elatus Lumbar Plate System | 5015-1426S | 5015-1426S | 2023-01-30 |
| 00840273321330 | Elatus Lumbar Plate System | 5015-1527S | 5015-1527S | 2023-01-30 |
| 00840273321347 | Elatus Lumbar Plate System | 5015-1628S | 5015-1628S | 2023-01-30 |
| 00840273321354 | Elatus Lumbar Plate System | 5015-1830S | 5015-1830S | 2023-01-30 |
| 00840273321637 | ZESPIN SI Joint Fusion System | SI01-0111 | SI01-0111 | 2023-01-31 |
| 00840273321644 | ZESPIN SI Joint Fusion System | SI01-0112 | SI01-0112 | 2023-01-31 |
| 00840273321651 | ZESPIN SI Joint Fusion System | SI01-0112A | SI01-0112A | 2023-01-31 |
| 00840273321668 | ZESPIN SI Joint Fusion System | SI01-0113 | SI01-0113 | 2023-01-31 |
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