SILVER OSTEOTOME 350-828

GUDID 00192896078437

SILVER OSTEOTOME WITH SINGLE GUARD LEFT CURVED TIP

SONTEC INSTRUMENTS, INC.

Orthopaedic osteotome handle

• Primary Device ID: 00192896078437
• NIH Device Record Key: 171c358a-c8a0-424e-91b4-921f2c861e82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SILVER OSTEOTOME
• Version Model Number: 350-828
• Catalog Number: 350-828
• 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	00192896078437 [Primary]

FDA Product Code

• HWM: OSTEOTOME

Sterilization

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

[00192896078437]

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: 2018-09-20

On-Brand Devices [SILVER OSTEOTOME]

• 00192896078444: SILVER OSTEOTOME WITH SINGLE GUARD RIGHT CURVED TIP
• 00192896078437: SILVER OSTEOTOME WITH SINGLE GUARD LEFT CURVED TIP
• 00192896078420: SILVER OSTEOTOME WITH SINGLE GUARD STRAIGHT TIP
• 00192896042995: SILVER OSTEOTOME SINGLE GUARD BLADE RIGHT CURVED TIP
• 00192896042988: SILVER OSTEOTOME SINGLE GUARD BLADE LEFT CURVED TIP
• 00192896042971: SILVER OSTEOTOME SINGLE GUARD BLADE STRAIGHT TIP