FDA UDI
In Commercial Distribution
🇺🇸 United States
SnapshotGLO
DI: B376KB1000
·
Model: KB100
·
Kent Imaging Inc
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SnapshotGLO
- Primary DI
- B376KB1000
- Version / Model
- KB100
- Company Name
- Kent Imaging Inc
- Labeler DUNS
- 246859016
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-10
- Public Version
- 1
- Public Version Date
- 2025-07-18
- Public Version Status
- New
- Public Device Record Key
- 0a03037d-6539-49d7-a27b-884c37904d95
Device Description
The SnapshotGLO is a portable, non-invasive optical imaging device designed to capture wound images under visible and fluorescence lighting. It combines a multispectral light source (including LEDs and a low-power laser) with a specialized camera to help healthcare professionals visualize and document wound characteristics such as size, shape, and fluorescence indicating bacterial contamination. The system includes embedded software for image capture, display, and storage, with an intuitive interface for point-of-care use.
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 |
|---|---|---|---|---|
| FXN | Tape, Camera, Surgical | General, Plastic Surgery | 878.4160 | 1 |
| QJF | Autofluorescence Imaging Adjunct Tool For Wounds | General, Plastic Surgery | 878.4550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63176 | Fluorescence wound imaging unit | A hand-held, electrically-powered device designed to use violet light illumination and imaging to visualize fluorescent bacteria within/around a wound to assist with wound care protocols and documentation. It includes a violet light(s) for wound illumination and fluorescence, lens, display screen, and includes video/image capture technology. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B376KB1000 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242669 | 000 |