FDA UDI
In Commercial Distribution
🇺🇸 United States
CORUS PCSS LevelOne, 4mm
DI: 00852776006683
·
Model: DX-50-405
·
Providence Medical Technology, Inc.
Product Codes
0
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CORUS PCSS LevelOne, 4mm
- Primary DI
- 00852776006683
- Version / Model
- DX-50-405
- 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
- 89ee63a8-18e8-41a2-a003-da5a279b727c
Device Description
Three related devices: CORUS PCSS Implant, CORUS Spinal System and DiViNE Portal System, referred to as “CORUS™ PCSS LevelOne” – which represents a combination of these devices.
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 |
| 61300 | Internal spinal fixation procedure kit, single-use | A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852776006683 | GS1 |