FDA UDI
In Commercial Distribution
🇺🇸 United States
Cross-Hair Reticule, XRETIC
DI: B365542250
·
Model: 54-225
·
Aktina Corp.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Cross-Hair Reticule, XRETIC
- Primary DI
- B365542250
- Version / Model
- 54-225
- Company Name
- Aktina Corp.
- Labeler DUNS
- 787178920
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-21
- Public Version
- 1
- Public Version Date
- 2021-05-31
- Public Version Status
- New
- Public Device Record Key
- 720d25ca-d0fb-4ebc-9231-481b67087460
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IWE | Monitor, Patient Position, Light-Beam | Radiology | 892.5780 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40892 | Patient positioning patterned-light instrument | A fixed or variable focal distance unit used to project a light pattern, e.g., grid or crosshatch, that aids in the positioning of patients during diagnostic imaging, radiation therapy, or treatment planning procedures. It is intended to enable precise and reproducible 1, 2, or multi-dimensional alignment of a selected portion(s) of the patient's anatomy with respect to the radiation beam or beams used for diagnostic or therapeutic procedures. Light-based positioning units can be freestanding units or incorporated as a component to a diagnostic imaging or radiation therapy system. It typically includes: a light bulb, a grid to shape the pattern, and mechanical/electronic controls. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B365542250 | HIBCC |