APRO 70 Catheter

GUDID 00850014025021

Alembic, LLC

Vascular guide-catheter, single-use
Primary Device ID00850014025021
NIH Device Record Key95048fc7-1ded-4730-a7ee-483013c46721
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPRO 70 Catheter
Version Model NumberAPRO-70-125
Company DUNS065914268
Company NameAlembic, 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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850014025021 [Primary]

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 Date2023-05-05
Device Publish Date2023-04-27

On-Brand Devices [APRO 70 Catheter]

00850014025038APRO-70-132
00850014025021APRO-70-125
00850014025014APRO-70-135
00850014025069FG-01016-N32

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.