INTEGRATED NEEDLEHOLDER

GUDID B09929013310

NEEDLEHOLDER WITH TUNGSTEN CARBIDE INSERTS CROSS-WISE TEETH STRAIGHT/ANGLED LUER LOCK SINGLE-ACTION

SONTEC INSTRUMENTS, INC.

Needle holder, reusable

• Primary Device ID: B09929013310
• NIH Device Record Key: 21177725-6c67-49d3-955b-742f1db10c80
• Commercial Distribution Discontinuation: 2018-06-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: INTEGRATED NEEDLEHOLDER
• Version Model Number: 2901-331
• 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

Device Dimensions

• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B09929013310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002877

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[B09929013310]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013310]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013310]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013310]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013310]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013310]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013310]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013310]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013310]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013310]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013310]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013310]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013310]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013310]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013310]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013310]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-19

On-Brand Devices [INTEGRATED NEEDLEHOLDER ]

• B09929013370: NEEDLE-HOLDER WITH TUNGSTEN CARBIDE INSERTS CROSS-WISE TEETH RIGHT CURVED/ANGLED LUER LOCK SINGL
• B09929013360: NEEDLE-HOLDER WITH TUNGSTEN CARBIDE INSERTS CROSS-WISE TEETH RIGHT CURVED/STRAIGHT LUER LOCK SIN
• B09929013350: NEEDLE-HOLDER WITH TUNGSTEN CARBIDE INSERTS CROSS-WISE TEETH LEFT CURVED/ANGLED LUER LOCK SINGLE
• B09929013340: NEEDLEHOLDER WITH TUNGSTEN CARBIDE INSERTS CROSS-WISE TEETH LEFT CURVED/STRAIGHT LUER LOCK SINGL
• B09929013310: NEEDLEHOLDER WITH TUNGSTEN CARBIDE INSERTS CROSS-WISE TEETH STRAIGHT/ANGLED LUER LOCK SINGLE-ACT
• B09929013300: NEEDLEHOLDER WITH TUNGSTEN CARBIDE INSERTS CROSS-WISE TEETH STRAIGHT/STRAIGHT LUER LOCK SINGLE-A