072 Aspiration System

GUDID 00857545008127

072 Aspiration Kit = 072 Aspiration System + 072 Aspiration Tubing

Q'APEL MEDICAL LLC

Thrombectomy suction catheter
Primary Device ID00857545008127
NIH Device Record Key6b29f966-a6ab-49fb-ac7b-366cc4870544
Commercial Distribution StatusIn Commercial Distribution
Brand Name072 Aspiration System
Version Model NumberFG 01252
Company DUNS020937374
Company NameQ'APEL MEDICAL LLC
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 Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857545008127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NRYCatheter, Thrombus Retriever

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-19
Device Publish Date2023-10-11