TruClear

GUDID 90884521744093

Dense Tissue Shaver Mini

Covidien LP

Tissue morcellation system

• Primary Device ID: 90884521744093
• NIH Device Record Key: 2340375f-c519-4901-b637-7f2c628c39c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruClear
• Version Model Number: 72204064
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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: 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

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521744097 [Primary]
GS1	90884521744093 [Package]; Contains: 10884521744097; Package: CASE [999 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161763

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: 4
• Public Version Date: 2021-08-31
• Device Publish Date: 2017-10-16

On-Brand Devices [TruClear]

• 00885556583685: Operative Sheath 5C
• 00885556583654: Operative Hysteroscope 5C
• 10884521749917: Control Unit, Refurbished
• 10884521749900: Handpiece, Refurbished
• 10884521749931: Control Unit
• 10884521767744: Elite Hysteroscope Mini, Refurbished
• 10884521767737: Elite Hysteroscope Plus, Refurbished
• 20884521750200: Elite Hysteroscope Seal
• 10884521746657: Elite Working Channel Insert Mini
• 10884521746640: Elite Working Channel Insert Plus
• 10884521746633: Elite Hysteroscope Mini
• 10884521746626: Elite Hysteroscope Plus
• 10884521749948: Footswitch
• 10884521749924: Handpiece
• 10884521746763: Sheath
• 10884521746695: Operative Hysteroscope 5C, Refurbished
• 10884521746671: Operative Hysteroscope, Refurbished
• 10884521746664: Operative Hysteroscope
• 10884521746756: Sheath 5C
• 10884521746688: Operative Hysteroscope 5C
• 10884521744158: Instrument Tray
• 10884521746749: Obturator
• 10884521746732: Sheath
• 90884521744093: Dense Tissue Shaver Mini
• 90884521744116: Dense Tissue Shaver Plus
• 90884521744109: Soft Tissue Shaver Plus
• 90884521744086: Soft Tissue Shaver Mini
• 10884521724709: Hysteroscope Seal Cap
• 10884521744141: Calibration Insert
• 10884521744134: Calibration Insert