Surgical Direct

Basic Information

• Brand Name: Surgical Direct
• Primary DI: B382SD9700600200
• Version / Model: SD970060020
• Catalog Number: SD970060020
• Company Name: Surgical Direct, Inc.
• Labeler DUNS: 124367223
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-06
• Public Version: 2
• Public Version Date: 2025-01-01
• Public Version Status: Update
• Public Device Record Key: aec72806-d53a-4d1a-ab02-1dda44b57def
• Distribution End Date: 2024-12-31

Device Description

Mouth Props Silicone Medium, Blue

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
FGN	RETRACTOR, NON-SELF-RETAINING	Gastroenterology, Urology	876.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16197	Mouth gag, non-adjustable	A mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention. It is designed to be inserted between the teeth to force the jaws apart and may be in the form of a wedge block, wedge screw, or sprung wedge. Depending on the design it may also be referred to as a jaw spreader, oral wood screw, or mouth prop. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B382SD9700600200	HIBCC

Customer Contacts

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