FDA UDI
In Commercial Distribution
🇺🇸 United States
Sun Nuclear MICRO+
DI: B136MLB3500
·
Model: MLB+350
·
SUN NUCLEAR CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Sun Nuclear MICRO+
- Primary DI
- B136MLB3500
- Version / Model
- MLB+350
- Catalog Number
- 805727
- Company Name
- SUN NUCLEAR CORP.
- Labeler DUNS
- 122240021
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-25
- Public Version
- 2
- Public Version Date
- 2023-01-09
- Public Version Status
- Update
- Public Device Record Key
- c6ceb4db-6792-458c-b29d-b6000e8bea74
Device Description
The MICRO+ MLB+350 Laser is used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. This product is used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which might present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied.
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 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 | B136MLB3500 | HIBCC |