FDA.reportPublic FDA data

EM45 SurgiFlexo Tip

Primary DI
E30722810003
Brand
EM45 SurgiFlexo Tip
Company
EURONDA SPA
Model
EM45
Catalog number
22810003
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 IlaDimensions: 18 cm 15,5 cm – without tipBox: 20pcs
Published
2024-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JOLCatheter And Tip, Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E307228100031PackageHIBCC20In Commercial Distribution
E307228100032PackageHIBCC24In Commercial Distribution
E30722810003PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction system cannula, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
428755441
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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Primary DI, Brand, Model table
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Primary DI, Brand, Company table
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