Armadillo SF7072-105-22-30

GUDID 00857545008042

SelectFlex II 072 Neurovascular Access System 105cm, 22cm Variable Stiffness, 30cm Coating

Q'APEL MEDICAL LLC

Vascular guide-catheter, single-use
Primary Device ID00857545008042
NIH Device Record Key424b8f52-0291-4862-ab1c-94fadf99cb79
Commercial Distribution StatusIn Commercial Distribution
Brand NameArmadillo
Version Model NumberFG 00464-05
Catalog NumberSF7072-105-22-30
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 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
GS100857545008042 [Primary]

FDA Product Code

DQYCatheter, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-24
Device Publish Date2022-01-16