NEEDLE HOLDER INSERT 2901-321S

GUDID B0992901321S0

NEEDLE HOLDER INSERT STRAIGHT SINGLE ACTION JAW TUNGSTEN CARBIDE SERRATED CROSSWISE TEETH FOR TUBE SHAFT

SONTEC INSTRUMENTS, INC.

Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable

• Primary Device ID: B0992901321S0
• NIH Device Record Key: 7bfc0936-035e-4879-8d5e-79b0e92f46e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEEDLE HOLDER INSERT
• Version Model Number: 2901-321S
• Catalog Number: 2901-321S
• 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

Device Dimensions

• 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
GS1	00192896007758 [Primary]
HIBCC	B0992901321S0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102921

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[B0992901321S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B0992901321S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B0992901321S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-08
• Device Publish Date: 2018-08-23

On-Brand Devices [NEEDLE HOLDER INSERT]

• B0992901337S0: NEEDLE HOLDER WITH TUNGSTEN CARBIDE INSERTS CROSSWISE TEETH RIGHT CURVED/ANGLED LUER LOCK SINGLE
• B0992901323S0: NEEDLE HOLDER WITH TUNGSTEN CARBIDE SERRATED CROSS-WISE TEETH RIGHT CURVED SINGLE-ACTION JAW FOR
• B0992901321S0: NEEDLE HOLDER INSERT STRAIGHT SINGLE ACTION JAW TUNGSTEN CARBIDE SERRATED CROSSWISE TEETH FOR TU