UNIVERSAL GRASPING FORCEPS INSERT

GUDID B09929012010

UNIVERSAL GRASPING FORCEPS DOUBLE-ACTION JAWS FOR TUBE SHAFT

SONTEC INSTRUMENTS, INC.

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

• Primary Device ID: B09929012010
• NIH Device Record Key: 724ccb10-a031-4629-b9ea-040a67eb5add
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIVERSAL GRASPING FORCEPS INSERT
• Version Model Number: 2901-201
• 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: 210 Millimeter
• Length: 210 Millimeter
• Length: 210 Millimeter
• Length: 210 Millimeter
• Length: 210 Millimeter
• Length: 210 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896007468 [Primary]
HIBCC	B09929012010 [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

[B09929012010]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09929012010]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09929012010]

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: 2018-08-22

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