OSTIUM BURNISHER ELEVATOR 1102-REBR43

GUDID 00192896050228

OSTIUM BURNISHER ELEVATOR #43 DOUBLE ENDED BALL TIPS LIGHT HANDLE

SONTEC INSTRUMENTS, INC.

Manual dental burnisher, reusable

• Primary Device ID: 00192896050228
• NIH Device Record Key: d786e8d5-428d-40aa-b120-c43f14f30a07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSTIUM BURNISHER ELEVATOR
• Version Model Number: 1102-REBR43
• Catalog Number: 1102-REBR43
• 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

• Outer Diameter: 1.6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896050228 [Primary]

FDA Product Code

• EKJ: BURNISHER, OPERATIVE

Sterilization

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

[00192896050228]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-09-09
• Device Publish Date: 2018-10-04

On-Brand Devices [OSTIUM BURNISHER ELEVATOR]

• 00192896050228: OSTIUM BURNISHER ELEVATOR #43 DOUBLE ENDED BALL TIPS LIGHT HANDLE
• 00192896050211: OSTIUM BURNISHER ELEVATOR #42 DOUBLE ENDED BALL TIPS LIGHT HANDLE
• 00192896050051: OSTIUM BURNISHER DOUBLE ENDED BALL TIP #43
• 00192896050044: OSTIUM BURNISHER ELEVATOR DOUBLE ENDED BALL TIPS #42