Primum Guiding Catheter 26102804

GUDID 38718122013985

The Hdrophilic Coated Gudidng Catheter is a single use device that facilitates the passage of intravascualar devices. Also available with two (2) Side Holes in the tip section.

PendraCare International B.V.

Vascular guide-catheter, single-use
Primary Device ID38718122013985
NIH Device Record Keyd0b09548-d9f3-4fd9-bc7d-e178de30501e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrimum Guiding Catheter
Version Model Number6F Primum JR4
Catalog Number26102804
Company DUNS413008652
Company NamePendraCare International B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108718122013984 [Primary]
GS138718122013985 [Package]
Contains: 08718122013984
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2026-02-10
Device Publish Date2026-02-02

On-Brand Devices [Primum Guiding Catheter]

38718122028897The Hydrophilic Coated Gudidng Catheter is a single use device that facilitates the passage of i
38718122013985The Hdrophilic Coated Gudidng Catheter is a single use device that facilitates the passage of in
08718122013915The Hdrophilic Coated Gudidng Catheter is a single use device that facilitates the passage of in

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.