SURGISTAR

Basic Information

• Brand Name: SURGISTAR
• Primary DI: 00878799004093
• Version / Model: 885562
• Company Name: SURGISTAR, INC.
• Labeler DUNS: 808865125
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-07
• Public Version: 2
• Public Version Date: 2020-02-06
• Public Version Status: Update
• Public Device Record Key: 67f9e4c1-7a99-45d2-8f69-822043dfba74

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
EMF	Knife, Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47569	Scalpel, single-use	A hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10878799004090	GS1		6	In Commercial Distribution
Primary	00878799004093	GS1

Customer Contacts

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