TRUCLEARTM ULTRA Plus Device 72203012

GUDID 00885554027617

TRUCLEAR ULTRA RECIPROCATING MORC. 4.0

Smith & Nephew, Inc.

Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered

• Primary Device ID: 00885554027617
• NIH Device Record Key: 3b58aa0a-ad9f-4654-bab0-18e9ee53b06c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUCLEARTM ULTRA Plus Device
• Version Model Number: 72203012
• Catalog Number: 72203012
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885554027617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041774

FDA Product Code

• HIH: HYSTEROSCOPE (AND ACCESSORIES)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-29

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