FDA UDI
In Commercial Distribution
🇺🇸 United States
Head & Neck Laser Alignment Tool
DI: 04719875623004
·
Model: 1.0
·
AMCAD BIOMED CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Head & Neck Laser Alignment Tool
- Primary DI
- 04719875623004
- Version / Model
- 1.0
- Company Name
- AMCAD BIOMED CORPORATION
- Labeler DUNS
- 656738726
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-31
- Public Version
- 1
- Public Version Date
- 2019-08-08
- Public Version Status
- New
- Public Device Record Key
- 31687248-e5b2-465f-a010-4734cdb0ea45
Device Description
Head & Neck Laser Alignment Tool is an apparatus for assisting pharyngeal/upper airway general purposed ultrasound scan. The apparatus can align the position of head and the general purposed ultrasound probe for automatic multiple-angle ultrasound scan.
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 40893 | Laser patient positioning system | A fixed or variable focal distance lasing device assembly designed to project a harmless beam (light pattern) onto a patient's skin or other alignment device. It is typically used to position and/or monitor the position of a patient during diagnostic imaging, radiation therapy, or radiation therapy treatment planning or simulation procedures. A set of these assemblies is used to enable precise and reproducible 1, 2, or multi-dimensional alignment of a selected portion(s) of the patient's anatomy with respect to a radiation beam(s) used during diagnostic or therapeutic procedures. It typically includes a light source, mechanical/electronic controls, and associated mounting devices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719875623004 | GS1 |