OSTEOTOME 330-794

GUDID 00192896030527

OSTEOTOME STRAIGHT TIP

SONTEC INSTRUMENTS, INC.

Orthopaedic osteotome

• Primary Device ID: 00192896030527
• NIH Device Record Key: f9c37f0e-12a4-4694-933a-44f3927ced27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSTEOTOME
• Version Model Number: 330-794
• Catalog Number: 330-794
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896030527 [Primary]

FDA Product Code

• HWM: OSTEOTOME

Sterilization

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

[00192896030527]

Dry Heat Sterilization;Moist Heat or Steam 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: 2018-09-20

On-Brand Devices [OSTEOTOME]

• 00192896030527: OSTEOTOME STRAIGHT TIP
• 00192896030497: OSTEOTOME STRAIGHT TIP
• 00192896030473: OSTEOTOME STRAIGHT TIP
• 00192896103665: Stille Type Osteotome
• 00192896106093: Black Ceramitec Osteotome V-Shaped