TITANIUM MICTEC OVAL TROCAR T20913-24

GUDID 00192896007918

TITANIUM MICTEC OVAL TROCAR FOR ENDO STAPLER SMOOTH

SONTEC INSTRUMENTS, INC.

Laparoscopic access cannula, reusable

• Primary Device ID: 00192896007918
• NIH Device Record Key: 35b6441c-fff4-48ec-9a36-31cef338b507
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TITANIUM MICTEC OVAL TROCAR
• Version Model Number: T20913-24
• Catalog Number: T20913-24
• Company DUNS: 040729840
• Company Name: SONTEC INSTRUMENTS, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 800-821-7496
• Email: info@sontecinstruments.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896007918 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002877

FDA Product Code

• HET: Laparoscope, Gynecologic (And Accessories)

Sterilization

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

[00192896007918]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-25
• Device Publish Date: 2018-08-15

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