FDA UDI
In Commercial Distribution
🇺🇸 United States
Lumicell Direct Visualization System (DVS)
DI: 00860003252505
·
Model: 810-00210
·
Lumicell, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Lumicell Direct Visualization System (DVS)
- Primary DI
- 00860003252505
- Version / Model
- 810-00210
- Company Name
- Lumicell, Inc.
- Labeler DUNS
- 832329788
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-19
- Public Version
- 1
- Public Version Date
- 2024-11-27
- Public Version Status
- New
- Public Device Record Key
- 161a6400-34be-4480-9d41-d821e05a0723
Device Description
Sterile Cover
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| SAW | Fluorescence Imaging For Breast Cancer Detection | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67340 | Intraoperative tumour margin fluorescence imaging system probe cover/spacer | A polymer sheath intended to be used to cover an intraoperative fluorescence imaging system probe (not included), to create a physical barrier between the patient and the probe, while optimising image acquisition by maintaining an ideal focal distance between the probe tip and the tissue, helping to focus the camera. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00860003252512 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00860003252505 | GS1 | ||||
| Package | 00860008537812 | GS1 | 2 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P230014 | 000 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 41 – 82.4 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 82.4 Degrees Fahrenheit