Quantum Spinal Fixation System
- Primary DI
- 00846468020439
- Brand
- Quantum Spinal Fixation System
- Company
- Pioneer Surgical Technology, Inc.
- Model
- 10-CADDY-HOOKS
- Catalog number
- 10-CADDY-HOOKS
- Device description
- CADDY, HOOK
- Published
- 2019-12-21
- 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 Codes
| Code | Name |
|---|
| FSM | TRAY, SURGICAL, INSTRUMENT |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00846468001919 | Primary | GS1 | 0 | |
| 00846468020439 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00846468001919 | 00846468001919 | 846468001919 | 0846468001919 |
| 00846468020439 | 00846468020439 | 846468020439 | 0846468020439 |
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 |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 793384496
- 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
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| 00840298702176 | CODA™ Anterior Cervical Plate System | 58-202203057 | 2022-03-057 | 2023-01-19 |
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