Identity
- Trade Name
- Sun Nuclear MICRO FDA UDI
- Generic Name
- Laser patient positioning system FDA UDI
- Device Name
- The MICRO MLB 150 lasers are intended to be used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. The micro lasers are intended to be 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. FDA UDI
- Model / Reference
- MLB 150 FDA UDI
- Description
- The MICRO MLB 150 lasers are intended to be used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. The micro lasers are intended to be 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. FDA UDI
Identifiers
- Catalog Number
- 805710 FDA UDI
- Primary DI / UDI-DI
- B136MLB1500 FDA UDI
- FDA Product Code
- IWE FDA UDI
- GMDN Term
- Laser patient positioning system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.5780 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Laser patient positioning system
Sun Nuclear MICRO by Sun Nuclear Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Manufacturer's product page: Sun Nuclear Patents
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sun Nuclear Corporation
Sources (1)
- FDA UDI 05790037-0ba2-48bc-9d7c-69457e2f686a 34 fields · synced Jun 8, 2026