FLEXIBLE TROCAR SLEEVE

GUDID B0991516171015

FLEXIBLE TROCAR SLEEVE PACKAGE OF 12

SONTEC INSTRUMENTS, INC.

Laparoscopic multi-instrument access port, reusable Laparoscopic multi-instrument access port, reusable Laparoscopic multi-instrument access port, reusable

• Primary Device ID: B0991516171015
• NIH Device Record Key: cdc3f66b-4bd2-47e7-9b90-1786b0a08a97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLEXIBLE TROCAR SLEEVE
• Version Model Number: 15-16171-01
• 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

• Width: 13 Millimeter
• Width: 13 Millimeter
• Width: 13 Millimeter
• Width: 13 Millimeter
• Width: 13 Millimeter
• Width: 13 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896000186 [Primary]
HIBCC	B0991516171015 [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

[B0991516171015]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B0991516171015]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B0991516171015]

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: 2018-12-31
• Device Publish Date: 2018-08-20

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