EM45 SurgiFlexo Tip

Basic Information

• Brand Name: EM45 SurgiFlexo Tip
• Primary DI: E30722810003
• Version / Model: EM45
• Catalog Number: 22810003
• Company Name: EURONDA SPA
• Labeler DUNS: 428755441
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-04
• Public Version: 1
• Public Version Date: 2024-12-12
• Public Version Status: New
• Public Device Record Key: c9241e4e-3269-4ef8-a9ed-78752dad72fb

Device Description

Flexible sterile aspirator tip suitable for surgical aspiration, especially for apicoectomies, gingival grafts and planetology operations with limited operating space. Ideal in hard-to-reach areas, such as in wisdom tooth operations. The possibility to flex the tube and unscrew the tip allows its adaptation to different aspiration needs during the various stages of the operation. Each aspirator tip is packed in a sterile medical blister with a double adhesive label to provide maximum traceability. Each pack includes 20 aspirator tips and 2 adapters: one adapter from 6,5 mm to 11 mm, the other from 11 mm to 16 mm, providing universal compatibility. Classification: Medical Device Class Ila Dimensions: 18 cm | 15,5 cm – without tip Box: 20pcs

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: 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
JOL	Catheter And Tip, Suction	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37434	Dental suction system cannula, single-use	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 typically made of disposable plastic materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E30722810003	HIBCC
Package	E307228100031	HIBCC	Box	20	In Commercial Distribution
Package	E307228100032	HIBCC	Carton	24	In Commercial Distribution