FDA UDI
In Commercial Distribution
🇺🇸 United States
Sunoptic Technologies
DI: M678SLS0
·
Model: Rover Lightsource series
·
SUNOPTIC TECHNOLOGIES LLC
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Sunoptic Technologies
- Primary DI
- M678SLS0
- Version / Model
- Rover Lightsource series
- Company Name
- SUNOPTIC TECHNOLOGIES LLC
- Labeler DUNS
- 094586898
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-27
- Public Version
- 3
- Public Version Date
- 2025-03-20
- Public Version Status
- Update
- Public Device Record Key
- ec60aad5-70f8-42ed-bbae-b85c9e9eaf06
Device Description
LED Rover Disoposable, Non-Sterile Series
Device Characteristics
- Single Use
- Yes
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FCW | Light Source, Fiberoptic, Routine | Gastroenterology, Urology | 876.1500 | 2 |
| FTD | Lamp, Surgical | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65349 | Open surgical site internal light | An electrically-powered, light-emitting device that includes a light source and is intended to be placed within, or nearly within, a surgical wound/site for illumination during open surgery. It may be fixed to a surgical instrument (e.g., a retractor) and typically operates with either fibreoptic or LED technology to create cold light. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M678SLS10 | HIBCC | 10 | In Commercial Distribution | ||
| Primary | M678SLS0 | HIBCC |
Customer Contacts
- Phone
- 904 737-7611
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity