NEEDLEHOLDER POSITIONER INSERT

GUDID B0992901324L0

NEEDLEHOLDER POSITIONER WITH TUNGSTEN CARBIDE DUST CONVEX/CONCAVE SINGLE-ACTION JAW FOR TUBE SHAFT

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: B0992901324L0
• NIH Device Record Key: 636f3339-9754-4f1d-86d0-de017f63fc55
• Commercial Distribution Discontinuation: 2018-06-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: NEEDLEHOLDER POSITIONER INSERT
• Version Model Number: 2901-324L
• 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: 450 Millimeter
• Device Size Text, specify: 0
• Length: 450 Millimeter
• Device Size Text, specify: 0
• Length: 450 Millimeter
• Device Size Text, specify: 0
• Length: 450 Millimeter
• Device Size Text, specify: 0
• Length: 450 Millimeter
• Device Size Text, specify: 0
• Length: 450 Millimeter
• Device Size Text, specify: 0
• Length: 450 Millimeter
• Device Size Text, specify: 0
• Length: 450 Millimeter
• Device Size Text, specify: 0
• Length: 450 Millimeter
• Device Size Text, specify: 0
• Length: 450 Millimeter
• Device Size Text, specify: 0
• Length: 450 Millimeter
• Device Size Text, specify: 0
• Length: 450 Millimeter
• Device Size Text, specify: 0
• Length: 450 Millimeter
• Device Size Text, specify: 0
• Length: 450 Millimeter
• Device Size Text, specify: 0
• Length: 450 Millimeter
• Device Size Text, specify: 0
• Length: 450 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0992901324L0 [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

[B0992901324L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992901324L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992901324L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992901324L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992901324L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992901324L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992901324L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992901324L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992901324L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992901324L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992901324L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992901324L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992901324L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992901324L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992901324L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992901324L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 8
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-19

On-Brand Devices [NEEDLEHOLDER POSITIONER INSERT]

• B0992901324S0: NEEDLEHOLDER POSITIONER WITH TUNGSTEN CARBIDE DUST CONVEX/CONCAVE SINGLE-ACTION JAW FOR TUBE SHA
• B0992901324L0: NEEDLEHOLDER POSITIONER WITH TUNGSTEN CARBIDE DUST CONVEX/CONCAVE SINGLE-ACTION JAW FOR TUBE SHA
• B09929013240: NEEDLEHOLDER POSITIONER WITH TUNGSTEN CARBIDE DUST CONVEX/CONCAVE SINGLE-ACTION JAW FOR TUBE SHA