Uscope

GUDID 16971176280033

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

Flexible video ureteroscope, reusable

• Primary Device ID: 16971176280033
• NIH Device Record Key: 97999be1-1c97-4024-8f11-9f498521f53d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uscope
• Version Model Number: UE3011
• Company DUNS: 544427443
• Company Name: Zhuhai Pusen Medical Technology Co, 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 2072148535
• Email: ellen.wang@pusenmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971176280036 [Primary]
GS1	16971176280033 [Package]; Contains: 06971176280036; Package: BOX [1 Units]; In Commercial Distribution
GS1	26971176280030 [Package]; Package: BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171076

FDA Product Code

• FGB: Ureteroscope And Accessories, Flexible/Rigid

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-23
• Device Publish Date: 2017-08-08

On-Brand Devices [Uscope]

• 16971176280033: This instrument has been designed to be used with endo-therapy accessories such as a biopsy forc
• 16971176280026: This instrument has been designed to be used with endo-therapy accessories such as a biopsy forc
• 16971176280019: This instrument has been designed to be used with endo-therapy accessories such as a biopsy forc
• 06971176280111: This instrument has been designed to be used with endo-therapy accessories such as a biopsy forc
• 16971176280439: This instrument has been designed to be used with endo-therapy accessories such as a biopsy forc
• 16971176280422: This instrument has been designed to be used with endo-therapy accessories such as a biopsy forc
• 16971176280415: This instrument has been designed to be used with endo-therapy accessories such as a biopsy forc
• 16971176281313: This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc
• 16971176281306: This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc
• 16971176281290: This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc
• 16971176281283: This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc
• 16971176281276: This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc
• 16971176281269: This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc
• 16971176281252: This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc
• 16971176281245: This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc
• 16971176281474: This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc
• 16971176281467: This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc
• 16971176281450: This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc
• 16971176281443: This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc
• 16971176281436: This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc
• 16971176281429: This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc
• 16971176281412: This instrument has been designed to be used with endo-therapy accessories such as a biopsy forc
• 16971176281405: This instrument has been designed to be used with endo-therapy accessories such as a biopsy forc