FDA UDI
In Commercial Distribution
🇺🇸 United States
StarTrol
DI: M5758X4GS10
·
Model: 8X4-GS1
·
HUOT INSTRUMENTS, LLC
Product Codes
4
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- StarTrol
- Primary DI
- M5758X4GS10
- Version / Model
- 8X4-GS1
- Catalog Number
- 8X4-GS1
- Company Name
- HUOT INSTRUMENTS, LLC
- Labeler DUNS
- 780642844
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-09
- Public Version
- 3
- Public Version Date
- 2021-01-08
- Public Version Status
- Update
- Public Device Record Key
- ec01fe18-f2d3-4ab5-9e41-d0dc931dff7c
Device Description
8 Pod Single Ceiling LED Light
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
- No
- 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 |
|---|---|---|---|---|
| FSY | Light, surgical, ceiling mounted | General, Plastic Surgery | 878.4580 | 2 |
| KZF | DEVICE, MEDICAL EXAMINATION, AC POWERED | General Hospital | 880.6320 | 1 |
| FTD | Lamp, surgical | General, Plastic Surgery | 878.4580 | 2 |
| FSS | Light, surgical, floor standing | General, Plastic Surgery | 878.4580 | 2 |
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 |
| 36843 | Mobile examination/treatment room light | A mobile 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), which reflect the light via reflectors or mirrors depending upon the construction, and will often be mounted on a pantograph counterbalance assembly that is attached to a mobile mount. It is usually used during examination or treatment in locations that do not have the required lighting installed. This device is designed to be easily moved from one location to another. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M5758X4GS10 | HIBCC |
Customer Contacts
- Phone
- +1(262)373-1700
- [email protected]