VersaCross Connect Transseptal Dilator

Primary DI
00685447010487
Brand
VersaCross Connect Transseptal Dilator
Company
Baylis Médicale Cie Inc
Model
VXA12-85-35-WM-D0
Device description
1 x VersaCross Connect Transseptal Dilator; 1 x J-Tip Guidewire (Single Use)
Published
2022-05-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DREDilator, Vessel, For Percutaneous Catheterization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00685447010487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00685447010487006854470104876854470104870685447010487

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 (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5144889801info@baylismedical.com

Regulatory Flags#

DUNS number
249225954
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00685447018841VersaCross Connect Transseptal DilatorVXA12-84-35-PS-D1NA2023-08-15
00685447010531VersaCross Connect Transseptal DilatorVXA12-85-35-WM-D1NA2022-05-19
00685447005247VersaCross Large Access Transseptal DilatorVLA125-35-67-D0NA2021-06-10
00685447005254VersaCross Large Access Transseptal DilatorVLA125-35-67-D1NA2021-06-10
00685447005261VersaCross Large Access Transseptal DilatorVLA125-35-85-D0NA2021-06-10
00685447005278VersaCross Large Access Transseptal DilatorVLA125-35-85-D1NA2021-06-10
00685447005735VersaCross Steerable SheathVST85-35-BD-71L-D0NA2021-04-08
00685447005759VersaCross Steerable SheathVST85-35-BD-71M-D0NA2021-04-08
00685447005766VersaCross Steerable SheathVST85-35-BD-71M-D1NA2021-04-08
00685447005780VersaCross Steerable SheathVST85-35-BD-71S-D1NA2021-04-08
00685447003380VersaCross Transseptal SheathVXS85-35-63-45-D02019-06-26
00685447003397VersaCross Transseptal SheathVXS85-35-63-55-D02019-06-26
00685447003281VersaCross RF WireVXW-35-180-J2019-05-01
00685447003298VersaCross RF WireVXW-35-180-P2019-05-01
00685447003304VersaCross RF WireVXW-35-230-J2019-05-01
00685447003311VersaCross RF WireVXW-35-230-P2019-05-01
00685447000938RFP-100A Connector CableRFX-BAY-OTW-12-SU2016-08-15
00685447001027Adult Dispersive ElectrodeRFA-GP-BAY2017-02-03
00685447011774VersaCross Access SolutionVXSK0026NA2022-07-08
00685447010272VersaCross Steerable Access SolutionVSTK00372022-05-09

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