Visionflex

GUDID 09352527000775

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.

VISIONFLEX PTY. LTD.

Surgical camera lens Surgical camera lens Surgical camera lens Surgical camera lens Surgical camera lens Surgical camera lens Surgical camera lens Surgical camera lens Surgical camera lens Surgical camera lens Surgical camera lens Surgical camera lens Surgical camera lens Surgical camera lens

• Primary Device ID: 09352527000775
• NIH Device Record Key: 97682cfd-31d8-4b59-9add-3d883d11cc5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visionflex
• Version Model Number: VFGEISCAM1.04
• Company DUNS: 752219480
• Company Name: VISIONFLEX PTY. LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09352527000775 [Primary]
GS1	09352527000782 [Package]; Package: Flip box [1 Units]; In Commercial Distribution
GS1	09352527000799 [Package]; Package: Aluminium Case [1 Units]; In Commercial Distribution

FDA Product Code

• FWB: Camera, Television, Surgical, Without Audio

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-25
• Device Publish Date: 2020-08-17

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