EM45 SurgiFlexo Tip 22810003

GUDID E30722810003

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

EURONDA SPA

Dental suction system cannula, single-use
Primary Device IDE30722810003
NIH Device Record Keyc9241e4e-3269-4ef8-a9ed-78752dad72fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameEM45 SurgiFlexo Tip
Version Model NumberEM45
Catalog Number22810003
Company DUNS428755441
Company NameEURONDA SPA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE30722810003 [Primary]
HIBCCE307228100031 [Package]
Package: Box [20 Units]
In Commercial Distribution
HIBCCE307228100032 [Package]
Contains: E307228100031
Package: Carton [24 Units]
In Commercial Distribution

FDA Product Code

JOLCatheter And Tip, Suction

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-12
Device Publish Date2024-12-04

Devices Manufactured by EURONDA SPA

E30722810003 - EM45 SurgiFlexo Tip2024-12-12Flexible 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
E30722810003 - EM45 SurgiFlexo Tip2024-12-12 Flexible sterile aspirator tip suitable for surgical aspiration, especially for apicoectomies, gingival grafts and planetology o
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