SURGISTAR

Basic Information

• Brand Name: SURGISTAR
• Primary DI: 00878799002860
• Version / Model: 8191
• 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: 3
• Public Version Date: 2018-12-07
• Public Version Status: Update
• Public Device Record Key: b68a7c60-2c09-4191-b9e1-ac0b93e29650

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
KCJ	Applicator, Ent	Ear, Nose, Throat	874.5220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33954	Cotton pledget applicator, single-use	A slender rod of wood, flexible metal, or synthetic material with a pledget of cotton attached at one end intended to be used for cleaning or applying a substance (e.g., medication) to superficial wounds or body orifices [e.g., ears, nose, oral cavity, throat, anus, rectum]. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10878799002867	GS1		6	In Commercial Distribution
Primary	00878799002860	GS1

Customer Contacts

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