BONE MALLET 330-839

GUDID 00192896094451

BONE MALLET AO TYPE PHENOLIC HANDLE

SONTEC INSTRUMENTS, INC.

Surgical mallet

• Primary Device ID: 00192896094451
• NIH Device Record Key: e0bad34a-af72-4bb1-84bc-0ab907bf225c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BONE MALLET
• Version Model Number: 330-839
• Catalog Number: 330-839
• 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: 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 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896094451 [Primary]

FDA Product Code

• HXL: MALLET

Sterilization

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

[00192896094451]

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

On-Brand Devices [BONE MALLET]

• 00192896078147: BONE MALLET
• 00192896078116: BONE MALLET WITH NYLON HEAD
• 00192896047624: BONE MALLET SOLID STAINLESS STEEL
• 00192896094451: BONE MALLET AO TYPE PHENOLIC HANDLE