FDA UDI
In Commercial Distribution
🇺🇸 United States
HexaLux
DI: 00724995244347
·
Model: HexaLux Light Mobile
·
STERIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HexaLux
- Primary DI
- 00724995244347
- Version / Model
- HexaLux Light Mobile
- Catalog Number
- EXLMBNBUS
- Company Name
- STERIS CORPORATION
- Labeler DUNS
- 036985604
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-05
- Public Version
- 1
- Public Version Date
- 2025-05-13
- Public Version Status
- New
- Public Device Record Key
- c99272e9-4866-45ae-9a75-4b868ff3c281
Device Description
The HexaLux Exam Mobile Light without Batteries is a powerful, next-generation LED exam light designed to be used in a multitude of rooms including the exam room, birthing suite, or intensive care unit.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| KZF | Device, medical examination, ac powered | General Hospital | 880.6320 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12276 | Fixed examination/treatment room light | A fixed device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s) and, depending upon the design, reflectors or mirrors which focus and reflect the light. The device can be fixed to a ceiling, wall, or supported on a mobile mount. It can also be part of an operating light system consisting of more than one light head. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | 00724995172527 | GS1 | ||||
| Primary | 00724995244347 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]