V.A.T.S. MAYO NEEDLE HOLDER

GUDID B09923009040

V.A.T.S. MAYO NEEDLE HOLDER WITH RATCHET TUNGSTEN CARBIDE SERRATED STRAIGHT

SONTEC INSTRUMENTS, INC.

Needle holder, reusable Needle holder, reusable Needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable

• Primary Device ID: B09923009040
• NIH Device Record Key: 3db454c9-1179-4e76-99ba-42307c81d58c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V.A.T.S. MAYO NEEDLE HOLDER
• Version Model Number: 2300-904
• 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
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com

Device Dimensions

• Length: 13 Inch
• Length: 13 Inch
• Length: 13 Inch
• Length: 13 Inch
• Length: 13 Inch
• Length: 13 Inch
• Length: 13 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 13 Inch
• Length: 13 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 13 Inch
• Length: 13 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 13 Inch
• Length: 13 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 13 Inch
• Length: 13 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 13 Inch
• Length: 13 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 13 Inch
• Length: 13 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 13 Inch
• Length: 13 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 13 Inch
• Length: 13 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 13 Inch
• Length: 13 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 13 Inch
• Length: 13 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 13 Inch
• Length: 13 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 13 Inch
• Length: 13 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 13 Inch
• Length: 13 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 13 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896004368 [Primary]
HIBCC	B09923009040 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152400

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[B09923009040]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09923009040]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09923009040]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09923009040]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09923009040]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09923009040]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09923009040]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09923009040]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09923009040]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09923009040]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09923009040]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09923009040]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09923009040]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09923009040]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09923009040]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09923009040]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09923009040]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09923009040]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09923009040]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09923009040]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09923009040]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09923009040]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09923009040]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09923009040]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09923009040]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09923009040]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09923009040]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09923009040]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09923009040]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09923009040]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09923009040]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-28
• Device Publish Date: 2018-08-28

On-Brand Devices [V.A.T.S. MAYO NEEDLE HOLDER]

• B09923009040: V.A.T.S. MAYO NEEDLE HOLDER WITH RATCHET TUNGSTEN CARBIDE SERRATED STRAIGHT
• B09923009020: V.A.T.S. MAYO NEEDLE HOLDER WITH RATCHET TUNGSTEN CARBIDE SERRATED CURVED
• B09923009000: V.A.T.S. MAYO NEEDLE HOLDER WITH RATCHET TUNGSTEN CARBIDE SERRATED STRAIGHT