AccessGUDID - DEVICE: SnapshotGLO (B376KB1000)

GUDID

Device Identifier (DI) Information

Brand Name: SnapshotGLO
Version or Model: KB100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Kent Imaging Inc

Primary DI Number: B376KB1000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 246859016 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FXN	Tape, Camera, Surgical
QJF	Autofluorescence Imaging Adjunct Tool For Wounds

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K242669	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0a03037d-6539-49d7-a27b-884c37904d95
Public Version Date: July 18, 2025
Public Version Number: 1
DI Record Publish Date: July 10, 2025