072 Aspiration System

GUDID 00857545008103

072 Aspiration Tubing

Q'APEL MEDICAL LLC

Thrombectomy suction catheter
Primary Device ID00857545008103
NIH Device Record Key4a3d151f-39be-4d62-ab61-2658acbe7cfd
Commercial Distribution StatusIn Commercial Distribution
Brand Name072 Aspiration System
Version Model NumberFG 00995
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
GS100857545008103 [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