TROCARHEAD 12-06370-03

GUDID 00192896008847

TROCARHEAD

SONTEC INSTRUMENTS, INC.

Laparoscopic multi-instrument access port, reusable

• Primary Device ID: 00192896008847
• NIH Device Record Key: 5bf9ccd1-73cf-4e2f-bf61-1273421d7164
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TROCARHEAD
• Version Model Number: 12-06370-03
• Catalog Number: 12-06370-03
• 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

• Length: 10.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896008847 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002877

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[00192896008847]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-01-22
• Device Publish Date: 2018-08-15

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