Tatum Scalpel Handle LH Offset

Basic Information

• Brand Name: Tatum Scalpel Handle LH Offset
• Primary DI: 00083208130281
• Version / Model: Tatum Offset Scalpel Handle (Left) SB-L
• Catalog Number: Scalpel Handle-SB-L
• Company Name: Suncoast Dental, Inc
• Labeler DUNS: 078352849
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-02
• Public Version: 1
• Public Version Date: 2021-02-10
• Public Version Status: New
• Public Device Record Key: 3db83eed-5da9-4f1f-94ec-bea698890b32

Device Description

Tatum Scalpel Handle LH Offset - Attaches to scalpel blade (not included) - to hold blade during cutting or dissection of tissue

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: No
• 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
DZN	Instruments, Dental Hand	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12235	Scalpel handle, reusable	A device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00083208130281	GS1

Customer Contacts

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