Axial Handle 2901-082

GUDID 00192896115774

Axial Handle Angled With Spring And Ratchet For 3 Millimeter, 5 Millimeter, and 10 Millimeter Diameter Tube Shafts

SONTEC INSTRUMENTS, INC.

Laparoscopic surgery handle

• Primary Device ID: 00192896115774
• NIH Device Record Key: 1da02ddf-c168-4180-83ff-193783f2b9e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axial Handle
• Version Model Number: 2901-082
• Catalog Number: 2901-082
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896115774 [Primary]

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

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

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: 2023-11-13
• Device Publish Date: 2023-11-03

Devices Manufactured by SONTEC INSTRUMENTS, INC.

• 00192896121621 - Gelpi Retractor: 2025-06-25 Gelpi Retractor Deep Angle With Enclosed Ratchet 6.5 Inches
• 00192896121638 - Debakey Neonatal Clamp: 2025-06-25 Debakey Neonatal Clamp Medium Full Curved Jaw/Shank A
• 00192896121645 - Debakey Neonatal Clamp: 2025-06-25 Debakey Neonatal Clamp Double Angled 45 Degrees Jaw/Shank A
• 00192896121652 - Debakey Scissors: 2025-06-25 Debakey Scissors 45 Degree Angle Power Cut
• 00192896121362 - Barraquer Iris Spatula: 2025-06-16 Barraquer Iris Spatula Round Smooth Curved Blades
• 00192896121607 - Micasept Top Dur Needle Holder: 2025-06-16 Micasept Top Dur Needle Holder With Hegar Ratchet Curved 4.5 Millimeter Tip
• 00192896121614 - Circular Cutting Punch: 2025-06-16 Circular Cutting Punch 70 Degree Upturned With Flushing Connector
• 00192896121577 - Stefan Mini Bone Holding Forceps: 2025-06-02 Stefan Mini Bone Holding Forceps With Speed Lock Serrated Jaw Curved Delicate Quantum