FDA UDI
In Commercial Distribution
🇺🇸 United States
NICO Corporation
DI: 00855373008043
·
Model: STX0350
·
SUNOPTIC TECHNOLOGIES LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NICO Corporation
- Primary DI
- 00855373008043
- Version / Model
- STX0350
- Catalog Number
- NN-9010
- Company Name
- SUNOPTIC TECHNOLOGIES LLC
- Labeler DUNS
- 094586898
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-03
- Public Version
- 1
- Public Version Date
- 2025-06-11
- Public Version Status
- New
- Public Device Record Key
- 18e2b319-19c1-4611-8372-1a4e1fa84f43
Device Description
Replacement 300-Watt Xenon Lamp Module for NICO Myriad-LX Light Source, Part Number NN-7064
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
- 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
- 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 |
|---|---|---|---|---|
| FSS | Light, Surgical, Floor Standing | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65951 | Procedural cold light bulb | An electrically-powered device in the form of a light bulb designed to be integrated into an appropriate light source unit (not included) to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities during surgery, examination, and/or endoscopy. It is a replaceable component of the assembly and does not include a light switch. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00855373008043 | GS1 |