FDA UDI
In Commercial Distribution
🇺🇸 United States
EZ-Track
DI: 00840314133045
·
Model: CAFB552415H
·
NEXT ORTHOSURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EZ-Track
- Primary DI
- 00840314133045
- Version / Model
- CAFB552415H
- Catalog Number
- CAFB552415H
- Company Name
- NEXT ORTHOSURGICAL, INC.
- Labeler DUNS
- 046767258
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-11
- Public Version
- 1
- Public Version Date
- 2024-09-19
- Public Version Status
- New
- Public Device Record Key
- dc7a2677-f086-4ee7-9298-0c984b018f46
Device Description
LLIF INTERBODY CAGE, 24 X 55 X 15MM -7°
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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | 888.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60458 | Visual input/output switching adaptor | A mains electricity (AC-powered) device intended to be used to manage the distribution of four digital visual interface (DVI) video sources to four DVI peripheral devices. It is typically used during endoscopic, microsurgical or open surgical procedures in an operating room (OR) or clinic to switch DVI-D (DVI-digital) compatible video signals from video capture sources (e.g., endoscope-/microscope-cameras, multi-purpose digital medical camera, surgical video camera, ultrasonic devices) to output devices (e.g., monitors, transmitters or encoding devices). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840314133045 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131082 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 24 | Millimeter | |
| Length | 55 | Millimeter | |
| Height | 15 | Millimeter | |
| Angle | 7 | degree |