F1 MPS Modular Pedicle Screw System
- Primary DI
- 00842048116752
- Brand
- F1 MPS Modular Pedicle Screw System
- Company
- DEGEN MEDICAL, INC.
- Model
- 0106-55065
- Catalog number
- 0106-55065
- Device description
- Rod, Straight, MIS, 5.5 X 65, Ti
- Published
- 2018-04-16
- 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
Related Records
Contact Domains
degenmedical.comProduct 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 |
|---|---|---|---|---|
| 00842048116752 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00842048116752 | 00842048116752 | 842048116752 | 0842048116752 |
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. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Outer Diameter | 5.5 | Millimeter |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | |
|---|---|
| +1(877)240-7838 | customerservice@degenmedical.com |
Regulatory Flags
- DUNS number
- 078812602
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- 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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