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.

• 00192896122093 - Ceramitec Ring Tip Forceps: 2025-09-22 Ceramitec Ring Tip Forceps Round Handle Tungsten Carbide Dust Straight 1 Millimeter Light Weight Tough Lock Black
• 00192896122109 - Easy Change Irrigation Aspiration System Tip: 2025-09-22 Easy Change Irrigation Aspiration System 45 Degrees Angled 0.5 Millimeters Tip Titanium
• 00192896122031 - Ceramitec Universal Klick Rongeur Handle: 2025-09-02 Ceramitec Universal Handle For Turnable Klick Rongeur
• 00192896122000 - Heartline Potts Vascular Scissors: 2025-08-19 Heartline Potts Vascular Scissors 45 Degrees Squeeze Handle
• 00192896122017 - Heartline Potts Vascular Scissors: 2025-08-19 Heartline Potts Vascular Scissors 90 Degrees Squeeze Handle
• 00192896122024 - Heartline Potts Vascular Scissors: 2025-08-19 Heartline Potts Vascular Scissors Miniature 125 Degrees Squeeze Handle
• 00192896121959 - Heartline Atrial Ball Lock: 2025-08-18 Heartline Atrial Ball Lock
• 00192896121966 - Heartline Crilewood Needle Holder: 2025-08-18 Heartline Crilewood Needle Holder With Lock Straight Tungsten Carbide Jaw Squeeze Handle