7.5cc Graft Tube Steel

Basic Information

• Brand Name: 7.5cc Graft Tube Steel
• Primary DI: 00858406007112
• Version / Model: GG-GTS-07
• Company Name: SURGENTEC, LLC
• Labeler DUNS: 004095409
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-12
• Public Version: 1
• Public Version Date: 2025-02-20
• Public Version Status: New
• Public Device Record Key: ee3121cb-8c13-4c3a-ab84-674d21e364ea

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64258	Syringe dose safety regulator	A non-powered device intended to be used by a healthcare provider to help safely administer a precise dose of medication from a (prefilled) syringe to a patient. It is in the form of a rod with volume graduations, secured alongside the syringe plunger, which includes a perpendicular sliding lock intended to mechanically obstruct the movement of the plunger into the syringe barrel beyond the desired volume mark, for safe medication administration. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858406007112	GS1

Premarket Submissions

Submission Number	Supplement Number
K170675	000