Uscope

GUDID 16971176280422

This instrument has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. This instrument is labeled Standard Deflection.

Zhuhai Pusen Medical Technology Co, Ltd

Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use

• Primary Device ID: 16971176280422
• NIH Device Record Key: 03f588a5-2cc2-4cdd-8971-39e517f01e59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uscope
• Version Model Number: PU3022
• 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 Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971176280425 [Primary]
GS1	16971176280422 [Package]; Contains: 06971176280425; Package: box [10 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: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-13
• Device Publish Date: 2022-12-05

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