87 NeuGlide Catheter 103577-004

GUDID 00860010306321

The 87 NeuGlide Catheter (103577-004) has an inner diameter of 0.087" (6F compatible), a maximum outer diameter of 0.100", and a working length of 100 cm.

PIRAEUS MEDICAL INC.

Vascular guide-catheter, single-use
Primary Device ID00860010306321
NIH Device Record Key265586c1-1c25-447c-bdf9-af380ea78103
Commercial Distribution StatusIn Commercial Distribution
Brand Name87 NeuGlide Catheter
Version Model Number103577-004
Catalog Number103577-004
Company DUNS128420207
Company NamePIRAEUS MEDICAL INC.
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860010306321 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QJPCatheter, Percutaneous, Neurovasculature

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-07-23
Device Publish Date2025-07-15

Devices Manufactured by PIRAEUS MEDICAL INC.

00860010306321 - 87 NeuGlide Catheter2025-07-23The 87 NeuGlide Catheter (103577-004) has an inner diameter of 0.087" (6F compatible), a maximum outer diameter of 0.100", and a working length of 100 cm.
00860010306321 - 87 NeuGlide Catheter2025-07-23 The 87 NeuGlide Catheter (103577-004) has an inner diameter of 0.087" (6F compatible), a maximum outer diameter of 0.100", and a
00860010306338 - 93 NeuFlex Catheter2025-06-26 The 93 NeuFlex Catheter (100148-001) has an inner diameter of 0.093” (6F compatible), a maximum outer diameter of 0.110”, an
00860010306345 - 93 NeuFlex Catheter2025-06-26 The 93 NeuFlex Catheter (100148-002) has an inner diameter of 0.093" (6F compatible), a maximum outer diameter of 0.110", and a
00860010306307 - Piraeus 87 NeuGlide2025-01-10 The 87 NeuGlide Catheter (103577-001) has an inner diameter of 0.087" (6F compatible), a maximum out diameter of 0.100", and a w
00860010306314 - Piraeus 87 NeuGlide2025-01-10 The 87 NeuGlide Catheter (103577-002) has an inner diameter of 0.087” (6F compatible), a maximum outer diameter of 0.100”, a

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.