Ergonomic Highly Rigid Plastic Ring Handle

GUDID 00192896114074

Ergonomic Highly Rigid Plastic Ring Handle With Ratchet And Ratchet Activating Release Lever Rotation Module And HF Connection

SONTEC INSTRUMENTS, INC.

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• Primary Device ID: 00192896114074
• NIH Device Record Key: 810ecb4c-3fbe-4fa2-8b2d-a47aae61b7c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ergonomic Highly Rigid Plastic Ring Handle
• Version Model Number: 2901-094
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896114074 [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

[00192896114074]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896114074]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896114074]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896114074]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896114074]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896114074]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896114074]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896114074]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896114074]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896114074]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896114074]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896114074]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896114074]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896114074]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896114074]

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: 2022-12-13
• Device Publish Date: 2022-12-05

On-Brand Devices [Ergonomic Highly Rigid Plastic Ring Handle]

• B09929010980: ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE WITH RATCHET/RATCHET ACTIVATING-DEACTIVATING KEY/ ROT
• B09929010960: ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE WITH ROTATION MODULE AND HIGH FREQUENCY CONNECTION
• B09929010920: ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE WITH STEPLESS RATCHET, RATCHET/RELEASE KEY, ROTATION
• B09929010940: ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE WITH RATCHET/RATCHET ACTIVATING/RELEASE LEVER, ROTATI
• B09929010900: ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE WITH STEPLESS RATCHET, RATCHET RELEASE/ ROTATION LEVE
• 00192896114074: Ergonomic Highly Rigid Plastic Ring Handle With Ratchet And Ratchet Activating Release Lever Rot