Seldin Retractor

Basic Information

• Brand Name: Seldin Retractor
• Primary DI: 00083208132025
• Version / Model: Seldin #23 Mini Flat
• Catalog Number: Seldin #23 Mini Flat
• Company Name: Suncoast Dental, Inc
• Labeler DUNS: 078352849
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-22
• Public Version: 1
• Public Version Date: 2021-12-30
• Public Version Status: New
• Public Device Record Key: 2155ec0b-732b-46c8-9757-d28cab5f9826

Device Description

Seldin retractor used to retract and protect soft tissue, to give better visualization and access a during surgery. This instrument has a handle that is wide, and flatter that the regular round handles.

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
EIG	Retractor, All Types	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13380	Hand-held dental retractor	A hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00083208132025	GS1

Customer Contacts

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