Home GUDID 00866749000202 Morph Universal Deflectable Guide Catheter
Primary DI 00866749000202
Brand Morph Universal Deflectable Guide Catheter
Company BIOCARDIA, INC.
Model 00895
Catalog number 00895
Published 2016-10-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name DQO Catheter, Intravascular, Diagnostic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQO Catheter, Intravascular, Diagnostic Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00866749000202 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00866749000202 00866749000202 866749000202 0866749000202
GMDN Terms# Term, Definition table Term Definition Vascular guide-catheter, single-use A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 122370146 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 false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850007221003 Avance Steerable Introducer AVA85-115-20 AVA85-115-20 2023-07-18 00850007221010 Avance Steerable Introducer AVA85-115-30 AVA85-115-30 2023-07-18 00850007221027 Avance Steerable Catheter AVA85-115-50 AVA85-115-50 2023-07-18 00866749000295 Morph DNA DNA55-115-30 DNA55-115-30 2023-07-17 00866749000240 Morph AccessPro Steerable Introducer MAP645 MAP645 2016-10-10 00866749000257 Morph AccessPro Steerable Introducer MAP690 MAP690 2016-10-10 00866749000271 Helical Infusion Catheter 00953L 00953L 2023-07-17
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