Tatum Surgical-Hand Tool

Basic Information

• Brand Name: Tatum Surgical-Hand Tool
• Primary DI: 00083208060243
• Version / Model: HT.06U
• Catalog Number: HT.06U
• Company Name: Suncoast Dental, Inc
• Labeler DUNS: 078352849
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-16
• Public Version: 1
• Public Version Date: 2019-05-24
• Public Version Status: New
• Public Device Record Key: 48011cb5-ceed-436e-b7bc-efa17fc45560

Device Description

Torque Wrench to 2.5mm Pentagon. Fits: Straight, Tapered and Integrity Implants 3.7-5.0

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61946	Surgical torque wrench adaptor	A component of a surgical wrench (typically ratchet type) intended to enable connection of the main body of the wrench to a variety of distal end pieces (bits). It is intended to be used during an invasive surgical procedure, and is not dedicated to dental use only. It may be referred to as a driver. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00083208060243	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			4.0mm Square Head