FDA UDI
In Commercial Distribution
🇺🇸 United States
DTRAX® Spinal System
DI: 00852776006089
·
Model: DX-22-100
·
PROVIDENCE MEDICAL TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DTRAX® Spinal System
- Primary DI
- 00852776006089
- Version / Model
- DX-22-100
- Catalog Number
- DX-22-100
- Company Name
- PROVIDENCE MEDICAL TECHNOLOGY, INC.
- Labeler DUNS
- 969820245
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-27
- Public Version
- 5
- Public Version Date
- 2019-03-29
- Public Version Status
- Update
- Public Device Record Key
- a0b1a72a-e599-4d5d-b787-195186a81dc5
Device Description
The DTRAX® Spinal System is a set of instruments intended and indicated for access and preparation of a spinal joint to aid in fusion.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HRX | Arthroscope | Orthopedic | 888.1100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32579 | Spinal endoscopic-access system | An assembly of devices used to gain access to the spine by dilation of the overlying tissues for the placement and support of an endoscope. It typically includes the endoscope, a light source, a fibreoptic light cable, a camera control unit, a camera, and cannulae (portals). It is used for posterior or anterior access and visualization of a surgical area of the cervical, thoracic, or lumbar spine, allowing the surgeon to perform a procedure such as, a discectomy, nucleotomy, spinal fusion, spinal decompression, foraminotomy, or insertion of spinal implants. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10852776006086 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 00852776006089 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180876 | 000 |