MICTEC OVAL TROCAR

GUDID B09920913180

MICTEC OVAL TROCAR FOR ENDO STAPLER WAVED

SONTEC INSTRUMENTS, INC.

Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable

• Primary Device ID: B09920913180
• NIH Device Record Key: a6f59c00-8c01-43d8-873b-555b380b01d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MICTEC OVAL TROCAR
• Version Model Number: 20913-18
• 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: 8008217496
• Email: INFO@SONTECINSTRUMENTS.COM
• Phone: 8008217496
• Email: INFO@SONTECINSTRUMENTS.COM
• Phone: 8008217496
• Email: INFO@SONTECINSTRUMENTS.COM

Device Dimensions

• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896007888 [Primary]
HIBCC	B09920913180 [Previous]

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

[B09920913180]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09920913180]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09920913180]

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: 2019-04-25
• Device Publish Date: 2018-08-23

On-Brand Devices [MICTEC OVAL TROCAR]

• B09920913240: MICTEC OVAL TROCAR FOR ENDO STAPLER SMOOTH
• B09920913180: MICTEC OVAL TROCAR FOR ENDO STAPLER WAVED