FDA UDI
In Commercial Distribution
🇺🇸 United States
CORUS PCSS Implant, 5mm
DI: 00852776006676
·
Model: DX-50-404
·
Providence Medical Technology, Inc.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CORUS PCSS Implant, 5mm
- Primary DI
- 00852776006676
- Version / Model
- DX-50-404
- Company Name
- Providence Medical Technology, Inc.
- Labeler DUNS
- 969820245
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-19
- Public Version
- 2
- Public Version Date
- 2025-03-06
- Public Version Status
- Update
- Public Device Record Key
- 030484e3-16a9-4e37-843d-1a29035af77c
Device Description
CORUS™ PCSS is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58109 | Implantable cervical facet joint distractor | A non-powered wedge-shaped device intended to be inserted within a cervical facet joint (spinal joint), i.e., intra-facet, for joint distraction; the distraction is intended to facilitate nerve root decompression and stabilization of the spine in the treatment of various spinal conditions. It is typically fenestrated or barbed and may incorporate a screw to expand to shape and/or to provide fixation within the joint and cervical spine stabilization. It typically includes single-use instruments (e.g., chisels, rasps) for implantation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852776006676 | GS1 |