UNIVERSAL ARM WITH TABLE CLAMP

GUDID B0995168280

UNIVERSAL ARM WITH TABLE CLAMP

SONTEC INSTRUMENTS, INC.

Externally-anchored laparoscopic retractor

• Primary Device ID: B0995168280
• NIH Device Record Key: abbb8240-4ec4-4675-901d-1f262fc7c7d2
• Commercial Distribution Discontinuation: 2018-06-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: UNIVERSAL ARM WITH TABLE CLAMP
• Version Model Number: 516-828
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0995168280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152400

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[B0995168280]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0995168280]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-26

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