Surgical Direct

Basic Information

• Brand Name: Surgical Direct
• Primary DI: B382SD80311
• Version / Model: SD8031
• Catalog Number: SD8031
• Company Name: Surgical Direct, Inc.
• Labeler DUNS: 124367223
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-02
• Public Version: 1
• Public Version Date: 2022-12-12
• Public Version Status: New
• Public Device Record Key: e15563af-4ec6-45fc-821d-8e99e914d152

Device Description

Anti-fog Kit, Sterile, Single use, 20 units

Device Characteristics

• Single Use: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HET	LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)	Obstetrics/Gynecology	884.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65462	Endoscope antifog sheath	A tubular sleeve designed to encompass an endoscope to direct the flow of carbon dioxide (CO2) insufflation gas to the distal end of the endoscope to prevent condensation and maintain a clear image of the intervention site. It is introduced through an endoscopic access trocar/cannula and involves switching the gas supply from the trocar/cannula to this sleeve. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B382SD80311	HIBCC

Customer Contacts

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