GBT FLOWCONTROL x 4

Basic Information

• Brand Name: GBT FLOWCONTROL x 4
• Primary DI: 07613353225940
• Version / Model: FV-112/A
• Company Name: E.M.S. Electro Medical Systems S.A.
• Labeler DUNS: 481233849
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-16
• Public Version: 1
• Public Version Date: 2026-02-24
• Public Version Status: New
• Public Device Record Key: 8428268b-5474-4da2-923c-c6ba424a360c

Device Description

GBT FLOWCONTROL x 4

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KOJ	Airbrush	Dental	872.6080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38759	Dental suction system cannula, reusable	A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is made of metal or plastic materials that can be sterilized. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613353225940	GS1

Premarket Submissions

Submission Number	Supplement Number
K253254	000