CSU BALFOUR RETRACTOR SET 1100-610-SET

GUDID 00192896088016

CSU BALFOUR RETRACTOR SET SINGLE BAR FENESTRATED BLADES

SONTEC INSTRUMENTS, INC.

Self-retaining surgical retractor, reusable

• Primary Device ID: 00192896088016
• NIH Device Record Key: 3f39b89d-d102-41fd-b449-2f9c56ac2fb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CSU BALFOUR RETRACTOR SET
• Version Model Number: 1100-610-SET
• Catalog Number: 1100-610-SET
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com

Device Dimensions

• Length: 7.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896088016 [Primary]

FDA Product Code

• FFO: RETRACTOR, SELF-RETAINING

Sterilization

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

[00192896088016]

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: 2018-10-22
• Device Publish Date: 2018-09-21

Devices Manufactured by SONTEC INSTRUMENTS, INC.

• 00192896113725 - Easy Change Irrigation Aspiration System Tip: 2025-02-19 Easy Change Irrigation Aspiration System Straight Visco Removal Tip Titanium
• 00192896113732 - Easy Change Irrigation Aspiration System Tip: 2025-02-19 Easy Change Irrigation Aspiration System Curved Visco Removal Tip Titanium
• 00192896121089 - Debakey Scissors: 2025-02-14 Debakey Scissors 45° Angle
• 00192896121096 - Heartline Scalpel Blade Holder: 2025-02-14 Heartline Scalpel Blade Holder Round Handle Angled Titanium
• 00192896121102 - Small Blade Pair for Debakey Retractor: 2025-02-14 Small Blade Pair for Debakey Retractor Child Size
• 00192896121119 - Medium Blade Pair for Debakey Retractor: 2025-02-14 Medium Blade Pair for Debakey Retractor Child Size
• 00192896121126 - Large Blade Pair for Debakey Retractor: 2025-02-14 Large Blade Pair for Debakey Retractor Child Size
• 00192896121133 - Purse String Clamp: 2025-02-14 Purse String Clamp 42 Millimeter Jaw