Visionflex

Basic Information

• Brand Name: Visionflex
• Primary DI: 09352527000775
• Version / Model: VFGEISCAM1.04
• Company Name: VISIONFLEX PTY. LTD.
• Labeler DUNS: 752219480
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-17
• Public Version: 1
• Public Version Date: 2020-08-25
• Public Version Status: New
• Public Device Record Key: 97682cfd-31d8-4b59-9add-3d883d11cc5f

Device Description

GEIS Camera (General Examination Imaging System) is a handheld device that can capture medical grade quality images and video in Full HD 1080p resolution at the touch of a button.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
FWB	Camera, Television, Surgical, Without Audio	General, Plastic Surgery	878.4160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32287	Surgical camera lens	An optical element of a surgical camera designed to change the degree of convergence or divergence of transmitted light to enable modification of viewed images (e.g., magnification, wide angle). It is made of glass and is available in a variety of dimensions. This is a non-sterilizable, reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09352527000775	GS1
Package	09352527000782	GS1	Flip box	1	In Commercial Distribution
Package	09352527000799	GS1	Aluminium Case	1	In Commercial Distribution