FLEXIBLE TROCAR SLEEVE

GUDID B0991516100765

FLEXIBLE TROCAR SLEEVE PACKAGE OF 12

SONTEC INSTRUMENTS, INC.

Laparoscopic multi-instrument access port, reusable

• Primary Device ID: B0991516100765
• NIH Device Record Key: cb6447b6-b991-4f33-8229-0f1ac079aa4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLEXIBLE TROCAR SLEEVE
• Version Model Number: 15-16100-76
• 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: false
• 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: 7 Millimeter
• Width: 7 Millimeter
• Width: 7 Millimeter
• Width: 7 Millimeter
• Width: 7 Millimeter
• Width: 7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896000148 [Primary]
HIBCC	B0991516100765 [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

[B0991516100765]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B0991516100765]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B0991516100765]

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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• B0991516141055: FLEXIBLE TROCAR SLEEVE PACKAGE OF 12
• B0991516141045: FLEXIBLE TROCAR SLEEVE PACKAGE OF 12
• B0991516100765: FLEXIBLE TROCAR SLEEVE PACKAGE OF 12
• B0991516100755: FLEXIBLE TROCAR SLEEVE PACKAGE OF 12
• B0991516100745: FLEXIBLE TROCAR SLEEVE PACKAGE OF 12