Surgical Direct

Basic Information

• Brand Name: Surgical Direct
• Primary DI: B382SD50000M0
• Version / Model: SD500-00m
• Catalog Number: SD500-00m
• Company Name: Surgical Direct, Inc.
• Labeler DUNS: 124367223
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-30
• Public Version: 1
• Public Version Date: 2022-12-08
• Public Version Status: New
• Public Device Record Key: a169a43a-1e99-4c57-b4a6-60d96a5c8cef

Device Description

Latex Free 10 ft insufflation tubing Luer Lock connector w .1 Micron Filter Sterile one time use, 10 u

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
NKC	Tubing/tubing with filter, insufflation, laparoscopic	Obstetrics/Gynecology	884.1730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38559	Insufflation gas conditioning tubing set	A collection of sterile and non-sterile devices intended to be used with an insufflation gas conditioning system and/or a laparoscopic gas distention system, or other gas source, to condition the insufflation gas stream [typically carbon dioxide (CO2)] by heating and humidifying it before introduction into the peritoneal cavity or a wound during laparoscopic or open surgery. It is available in various configurations but typically includes a connection tube for connection to the gas source, an electrically-heated tube for transport of the conditioned gas to the operative site, a humidification chamber, a gas filter, and connectors. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B382SD50000M0	HIBCC

Customer Contacts

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