TRUCLEARTM 7211067

GUDID 03596010529497

CALIBRATION INSERT DISPOSABLE

Smith & Nephew, Inc.

Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system

• Primary Device ID: 03596010529497
• NIH Device Record Key: e97e6d58-d04c-40df-bad0-fd7282d8f6b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUCLEARTM
• Version Model Number: 7211067
• Catalog Number: 7211067
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010529497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031616

FDA Product Code

• HIG: INSUFFLATOR, HYSTEROSCOPIC

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: 2020-01-31
• Device Publish Date: 2015-09-21

On-Brand Devices [TRUCLEARTM]

• 00885554030549: TRUCLEAR UNIVERSAL OP. HYST. STOPCOCK SE
• 00885554020144: TRUECLEAR SHEATH 5.5
• 03596010529497: CALIBRATION INSERT DISPOSABLE