Flexible Sleeves

GUDID 00192896112179

Flexible Sleeves

SONTEC INSTRUMENTS, INC.

Laparoscopic multi-instrument access port, reusable

• Primary Device ID: 00192896112179
• NIH Device Record Key: 65901824-fbb7-4440-8f1c-6fe8fb54fa17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexible Sleeves
• Version Model Number: 15-16050-72
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896112179 [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

[00192896112179]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896112179]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896112179]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896112179]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896112179]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896112179]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896112179]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896112179]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896112179]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896112179]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896112179]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896112179]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896112179]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896112179]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896112179]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896112179]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-10
• Device Publish Date: 2021-12-31

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