BLUE BIPOLAR HARDY BAYONET FORCEPS

GUDID B09927009600

BLUE BIPOLAR HARDY BAYONET FORCEPS IRRIGATED STOP

SONTEC INSTRUMENTS, INC.

Endoscopic electrosurgical handpiece/electrode, bipolar, reusable

• Primary Device ID: B09927009600
• NIH Device Record Key: 26d1964d-8674-4bb7-b214-8ad3e6f20e41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLUE BIPOLAR HARDY BAYONET FORCEPS
• Version Model Number: 2700-960
• 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: 8.5 Inch
• Length: 8.5 Inch
• Length: 8.5 Inch
• Length: 8.5 Inch
• Length: 8.5 Inch
• Length: 8.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896006560 [Primary]
HIBCC	B09927009600 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101080

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[B09927009600]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09927009600]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09927009600]

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

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