FDA UDI
In Commercial Distribution
🇺🇸 United States
HexaLux
DI: 10724995245457
·
Model: EXLHAN3
·
STERIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
3
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Basic Information
- Brand Name
- HexaLux
- Primary DI
- 10724995245457
- Version / Model
- EXLHAN3
- Catalog Number
- EXLHAN3
- Company Name
- STERIS CORPORATION
- Labeler DUNS
- 036985604
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- 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
- 313cbb5a-7f62-4a21-aac9-56e592a3b857
Device Description
The HexaLux Sterilizable Light Handle is used with the HexaLux Exam Light.
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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44975 | Medical equipment handle cover, reusable | A device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a rigid polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00724995245450 | GS1 | ||||
| Primary | 10724995245457 | GS1 | ||||
| Previous | 10724995172500 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]