CSU BABY BALFOUR RETRACTOR 1100-611B

GUDID 00192896048447

CSU PEDIATRIC BALFOUR RETRACTOR DOUBLE BAR

SONTEC INSTRUMENTS, INC.

Self-retaining surgical retractor, reusable

• Primary Device ID: 00192896048447
• NIH Device Record Key: 384cde59-df9d-47ab-be3e-f53da7843bea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CSU BABY BALFOUR RETRACTOR
• Version Model Number: 1100-611B
• Catalog Number: 1100-611B
• 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 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896048447 [Primary]

FDA Product Code

• FFO: RETRACTOR, SELF-RETAINING

Sterilization

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

[00192896048447]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-05-21
• Device Publish Date: 2018-09-14

On-Brand Devices [CSU BABY BALFOUR RETRACTOR]

• 00192896048454: CSU PEDIATRIC BALFOUR RETRACTOR DOUBLE BAR FENESTRATED SIDE BLADES
• 00192896048447: CSU PEDIATRIC BALFOUR RETRACTOR DOUBLE BAR