Stellar Guide Catheter N/A

GUDID 00840303713586

Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. The distal tip of the catheter shaft includes a marker band while the proximal end of the catheter has a luer fitting to allow attachment of accessories and infusion of liquids through the system. The Stellar Guide Catheter distal shaft has an external hydrophilic coating which provides a lubricious surface during use. The Stellar Guide Catheter is visible under fluoroscopy. The Stellar Guide Catheter is offered in various sizes to accommodate physician preferences and anatomical variations. A peelable split introducer sheath is provided in the package to provide support and facilitate the introduction of the distal tip of the Stellar Guide Catheter into an appropriate vascular sheath. The catheter and introducer sheath are provided sterile, non-pyrogenic, and are intended for single use use only.

BALT USA LLC

Vascular guide-catheter, single-use
Primary Device ID00840303713586
NIH Device Record Keyc1678703-de4e-4521-b113-faf74229c2aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameStellar Guide Catheter
Version Model NumberSTLR074115
Catalog NumberN/A
Company DUNS945543689
Company NameBALT USA 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

Customer Support Contacts

Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com

Device Dimensions

Length115 Centimeter
Length115 Centimeter
Length115 Centimeter
Length115 Centimeter
Length115 Centimeter
Length115 Centimeter
Length115 Centimeter
Length115 Centimeter
Length115 Centimeter
Length115 Centimeter
Length115 Centimeter
Length115 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store the Stellar Guide Catheter in a cool, dry, place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Stellar Guide Catheter in a cool, dry, place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Stellar Guide Catheter in a cool, dry, place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Stellar Guide Catheter in a cool, dry, place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Stellar Guide Catheter in a cool, dry, place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Stellar Guide Catheter in a cool, dry, place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Stellar Guide Catheter in a cool, dry, place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Stellar Guide Catheter in a cool, dry, place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Stellar Guide Catheter in a cool, dry, place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Stellar Guide Catheter in a cool, dry, place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Stellar Guide Catheter in a cool, dry, place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Stellar Guide Catheter in a cool, dry, place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.

Device Identifiers

Device Issuing AgencyDevice ID
GS100840303713586 [Primary]

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 Date2025-06-17
Device Publish Date2025-06-09

On-Brand Devices [Stellar Guide Catheter]

00840303709671The Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. T
00840303709664The Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. T
00840303709657The Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. T
00840303709640The Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. T
00840303709633The Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. T
00840303709626The Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. T
00840303709619The Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. T
00840303713586Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. The d
00840303713579Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. The d
00840303713562Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. The d
00840303713555Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. The d
00840303713548Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. The d
00840303713531Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. The d

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