Eview

GUDID 16971176280002

This instrument has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and en

Zhuhai Pusen Medical Technology Co, Ltd

Endoscopic video image processing unit

• Primary Device ID: 16971176280002
• NIH Device Record Key: 80d6628d-5b0b-4fae-bbeb-18a1c3b6bd95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eview
• Version Model Number: UTV100
• Company DUNS: 544427443
• Company Name: Zhuhai Pusen Medical Technology Co, Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971176280005 [Primary]
GS1	16971176280002 [Package]; Contains: 06971176280005; Package: BOX [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172098

FDA Product Code

• FGB: Ureteroscope And Accessories, Flexible/Rigid

Sterilization

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

[16971176280002]

High-level Disinfectant

[16971176280002]

High-level Disinfectant

[16971176280002]

High-level Disinfectant

[16971176280002]

High-level Disinfectant

[16971176280002]

High-level Disinfectant

[16971176280002]

High-level Disinfectant

[16971176280002]

High-level Disinfectant

[16971176280002]

High-level Disinfectant

[16971176280002]

High-level Disinfectant

[16971176280002]

High-level Disinfectant

[16971176280002]

High-level Disinfectant

[16971176280002]

High-level Disinfectant

[16971176280002]

High-level Disinfectant

[16971176280002]

High-level Disinfectant

[16971176280002]

High-level Disinfectant

[16971176280002]

High-level Disinfectant

[16971176280002]

High-level Disinfectant

[16971176280002]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-21
• Device Publish Date: 2017-09-12

On-Brand Devices [Eview]

• 16971176280002: This instrument has been designed to be used with endo-therapy accessories such as a biopsy forc
• 06971176280043: This equipment has been designed to be used to process signals from an endoscope and convert it
• 06971176280135: This equipment has been designed to be used to process signals from an endoscope and convert it
• 06971176280241: This instrument has been designed to be used to process signals from a video endoscope and conve