Coronary Artery Probe 1.75mm

Primary DI
B040CPH175
Brand
Coronary Artery Probe 1.75mm
Company
GENESEE BIOMEDICAL, INC.
Model
CPH-1.75
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
OTC
false
Sterile
false
Single use
false

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
B040CPH175PackageHIBCC1In Commercial Distribution
B040CPH1750PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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