SURGISTAR

Basic Information

• Brand Name: SURGISTAR
• Primary DI: 00878799008077
• Version / Model: 501030
• Company Name: SURGISTAR, INC.
• Labeler DUNS: 808865125
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-02
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: c9fd229e-1fb6-478b-b844-c7bb1706756c

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BSN	Filter, Conduction, Anesthetic	Anesthesiology	868.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47800	Surgical fluid/gas irrigator	A sterile, hand-operated surgical device intended for the controlled delivery of medical gas and fluid (e.g., saline solution) to an open surgical site to improve visibility, by clearing bloody fluids/debris, and to prevent tissue desiccation. It is typically made of plastic materials [e.g., polypropylene, polyvinyl chloride (PVC)] and may be double-lumen for nebulization of fluid/gas, or dual-line for separate fluid and gas administration and include an antibacterial filter. It typically includes a nozzle at the distal end and connector(s) [e.g., Luer] at the proximal end for connection to the fluid/gas sources; a manual tubing clamp may also be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10878799008074	GS1		50	In Commercial Distribution
Primary	00878799008077	GS1

Customer Contacts

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