AccessGUDID - DEVICE: Gendex GXC-300™ intraoral camera (EKAV082243310)

GUDID

Device Identifier (DI) Information

Brand Name: Gendex GXC-300™ intraoral camera
Version or Model: 0.822.4331
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GXC300
Company Name: GENDEX CORP.

Primary DI Number: EKAV082243310
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 144575763 *Terms of Use

Device Description: Digital intraoral camera

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	Yes
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?
58857	Multi-purpose digital medical camera	An electrically-powered, hand-held digital electro-optical device designed to capture video or still image data for multiple medical applications (e.g., ophthalmoscopic, otoscopic, and dermatoscopic) using dedicated interchangeable lenses/attachments. It typically consists of a lightproof chamber with an aperture fitted with a lens and a shutter, through which the image of an object is projected onto a surface for recording. It may include a user display screen for visualization before image capture, and sometimes a docking cradle for battery recharging and connection to a personal computer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIA	UNIT, OPERATIVE DENTAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040691	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
Handling Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b373d4bf-9daf-4897-95dd-0c13790d0340
Public Version Date: January 31, 2022
Public Version Number: 6
DI Record Publish Date: September 24, 2016