SPINAL DISTRACTOR 416-603

GUDID 00192896095403

SPINAL DISTRACTOR ANGLED

SONTEC INSTRUMENTS, INC.

Orthopaedic surgical distractor, internal

• Primary Device ID: 00192896095403
• NIH Device Record Key: 9ed89565-d7f0-450e-b106-a62faf37af4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPINAL DISTRACTOR
• Version Model Number: 416-603
• Catalog Number: 416-603
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: +1(800) 821-7496
• Email: info@sontecinstruments.com

Device Dimensions

• Length: 9.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896095403 [Primary]

FDA Product Code

• HWN: INSTRUMENT, COMPRESSION

Sterilization

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

[00192896095403]

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: 2019-03-15
• Device Publish Date: 2019-03-07

On-Brand Devices [SPINAL DISTRACTOR]

• 00192896037595: SPINAL DISTRACTOR ANGLED LARGE
• 00192896037588: SPINAL DISTRACTOR
• 00192896095403: SPINAL DISTRACTOR ANGLED