BALFOUR RETRACTOR 1100-606

GUDID 00192896097759

BALFOUR RETRACTOR WITH DOUBLE BAR FENESTRATED SIDE BLADES

SONTEC INSTRUMENTS, INC.

Self-retaining surgical retractor, reusable

• Primary Device ID: 00192896097759
• NIH Device Record Key: 3783f2da-331a-40e7-8169-7c808afaa31a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BALFOUR RETRACTOR
• Version Model Number: 1100-606
• Catalog Number: 1100-606
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Length: 7 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896097759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100736

FDA Product Code

• FFO: Retractor, Self-Retaining
• HTY: Pin, Fixation, Smooth

Sterilization

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

[00192896097759]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-07-09
• Device Publish Date: 2019-06-17

On-Brand Devices [BALFOUR RETRACTOR]

• 00192896081819: BALFOUR RETRACTOR LARGE SPREAD
• 00192896072077: BALFOUR RETRACTOR DOUBLE BAR FENESTRATED SIDE BLADE
• 00192896072060: BALFOUR RETRACTOR DOUBLE BAR FENESTRATED SIDE BLADE
• 00192896072053: BALFOUR RETRACTOR DOUBLE BAR
• 00192896072046: BALFOUR RETRACTOR
• 00192896071988: BALFOUR RETRACTOR WITH DOUBLE BAR DETACHABLE WIRE BLADES
• 00192896071964: BALFOUR RETRACTOR LARGE SIZE
• 00192896071957: BALFOUR RETRACTOR WITH DOUBLE BAR
• 00192896071940: BALFOUR RETRACTOR WITH DOUBLE BAR FENESTRATE SIDE BLADES
• 00192896097759: BALFOUR RETRACTOR WITH DOUBLE BAR FENESTRATED SIDE BLADES
• 00192896097773: BALFOUR RETRACTOR DOUBLE BAR WITH DETACHABLE WIRE BLADES
• 00192896097766: BALFOUR RETRACTOR DOUBLE BAR SPREAD
• 00192896094918: BALFOUR RETRACTOR DOUBLE BAR WITH BLADES