INTEGRATED NEEDLEHOLDER

GUDID B09929013350

NEEDLE-HOLDER WITH TUNGSTEN CARBIDE INSERTS CROSS-WISE TEETH LEFT CURVED/ANGLED LUER LOCK SINGLE-ACTION

SONTEC INSTRUMENTS, INC.

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

• Primary Device ID: B09929013350
• NIH Device Record Key: 3d06935b-c646-4c1f-805b-eecd801399f8
• Commercial Distribution Discontinuation: 2018-06-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: INTEGRATED NEEDLEHOLDER
• Version Model Number: 2901-335
• 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

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	B09929013350 [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

[B09929013350]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013350]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013350]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013350]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013350]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013350]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013350]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013350]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013350]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013350]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013350]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013350]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013350]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013350]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013350]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929013350]

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: 2016-07-27

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