Lewin Bone Holding Clamp

GUDID 00192896109544

Lewin Bone Holding Clamp Modified Serrations

SONTEC INSTRUMENTS, INC.

Bone approximation clamp

• Primary Device ID: 00192896109544
• NIH Device Record Key: c37f5e93-bf22-4523-a447-08a94f5407d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lewin Bone Holding Clamp
• Version Model Number: 1100-426M
• Company DUNS: 040729840
• Company Name: SONTEC INSTRUMENTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Dimensions

• Length: 7.5 Inch
• Length: 7.5 Inch
• Length: 7.5 Inch
• Length: 7.5 Inch
• Length: 7.5 Inch
• Length: 7.5 Inch
• Length: 7.5 Inch
• Length: 7.5 Inch
• Length: 7.5 Inch
• Length: 7.5 Inch
• Length: 7.5 Inch
• Length: 7.5 Inch
• Length: 7.5 Inch
• Length: 7.5 Inch
• Length: 7.5 Inch
• Length: 7.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896109544 [Primary]

FDA Product Code

• GDJ: CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Sterilization

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

[00192896109544]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896109544]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896109544]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896109544]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896109544]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896109544]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896109544]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896109544]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896109544]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896109544]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896109544]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896109544]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896109544]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896109544]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896109544]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896109544]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-06
• Device Publish Date: 2021-04-28

On-Brand Devices [Lewin Bone Holding Clamp]

• 00192896047532: LEWIN BONE REDUCTION CLAMP
• 00192896109544: Lewin Bone Holding Clamp Modified Serrations
• 00192896109520: Lewin Bone Holding Clamp Quantum
• 00192896109940: Lewin Bone Holding Clamp With Long Double Ratchet Quantum