Coronary Artery Probe 2.75mm

Primary DI
B040CPH2750
Brand
Coronary Artery Probe 2.75mm
Company
GENESEE BIOMEDICAL, INC.
Model
CPH-2.75
Device description
Reusable Probe for Coronary Arteries Assorted sizes 1mm to 3mm as indicated by its part number 140mm Length
Published
2024-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K901531000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K901531000PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBEPioneering Technologies, Inc.1990-06-20DNP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B040CPH275PackageHIBCC1In Commercial Distribution
B040CPH2750PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular dilator, reusableA hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
939872651
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

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