FDA.reportPublic FDA data

Cruzar Medsystems Inc.

Primary DI
00860554000334
Brand
Cruzar Medsystems Inc.
Company
CRUZAR MEDSYSTEMS INC
Model
CM-3400
Device description
The Houdini Catheter is a single use, dual-lumen intravascular catheter intended for percutaneous use. The Houdini Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.
Published
2016-08-26
Public version status
Update
Distribution status
Not 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
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860554000334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860554000334008605540003348605540003340860554000334

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0
Device Size Text, specify0
Length0
Lumen/Inner Diameter0
Pressure0

Regulatory Flags#

DUNS number
080338871
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860554000303Cruzar Medsystems Inc.CM-36022022-12-12
00860554000372Cruzar Medsystems Inc.CM-35022022-12-12
00860554000327Cruzar Medsystems Inc.CM-37002016-08-26
00860554000358Cruzar Medsystems Inc.CM-38002016-08-26
00860554000365Cruzar Medsystems Inc.CM-35002016-08-26
00860554000396Cruzar Medsystems Inc.CM-36002016-08-26

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Primary DI, Brand, Company table
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