175IBLSSC

GUDID 28053323800020

Catheter Injection port

ELCAM MEDICAL ITALY SPA

Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port Catheter injection port
Primary Device ID28053323800020
NIH Device Record Key137d93aa-4323-424e-9eb6-22cc89522633
Commercial Distribution StatusIn Commercial Distribution
Brand Name175IBLSSC
Version Model Number175IBLSSC
Company DUNS513976688
Company NameELCAM MEDICAL ITALY SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108053323800026 [Primary]
GS118053323800023 [Package]
Contains: 08053323800026
Package: [100 Units]
In Commercial Distribution
GS128053323800020 [Package]
Contains: 18053323800023
Package: [1000 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCEAdaptor, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-07-27
Device Publish Date2019-02-26

Devices Manufactured by ELCAM MEDICAL ITALY SPA

28053323800020 - 175IBLSSC2023-07-27Catheter Injection port
28053323800020 - 175IBLSSC2023-07-27 Catheter Injection port
08053323800019 - 07103300/S2019-06-07

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