AXIAL RING HANDLE

GUDID B09929010760

AXIAL HANDLE WITH SPRING & RATCHET

SONTEC INSTRUMENTS, INC.

Laparoscopic surgical procedure kit, non-medicated, reusable

• Primary Device ID: B09929010760
• NIH Device Record Key: 4f6db467-7c6c-4cc3-95df-46cb2b68a81b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AXIAL RING HANDLE
• Version Model Number: 2901-076
• 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
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896007369 [Primary]
HIBCC	B09929010760 [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

[B09929010760]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929010760]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929010760]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929010760]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929010760]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929010760]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929010760]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929010760]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929010760]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929010760]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929010760]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929010760]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929010760]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929010760]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929010760]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929010760]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929010760]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929010760]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929010760]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929010760]

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: 2018-09-24
• Device Publish Date: 2018-08-22

On-Brand Devices [AXIAL RING HANDLE]

• B09929010760: AXIAL HANDLE WITH SPRING & RATCHET
• B09929010740: AXIAL RING HANDLE WITHOUT RATCHET
• B09929010700: AXIAL RING HANDLE WITH RATCHET
• B09929010860: AXIAL HANDLE WITH BRANCHES & RATCHET ANGLED WITHOUT FLUSHING
• B09929010840: AXIAL HANDLE WITH BRANCHES & RATCHET ANGLED
• B09929010820: AXIAL HANDLE WITH SPRING & RATCHET ANGLED
• B09929010800: AXIAL HANDLE WITH SPREADING SPRING
• B09929010780: AXIAL HANDLE WITH BRANCHES & RATCHET
• B09929010720: AXIAL RING HANDLE WITH RATCHET