FDA.reportPublic FDA data

TorFlex Transseptal Guiding Sheath

Primary DI
00685447001645
Brand
TorFlex Transseptal Guiding Sheath
Company
Baylis Médicale Cie Inc
Model
TF8-32-63-90
Device description
TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
Published
2016-11-22
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous
DREDilator, Vessel, For Percutaneous Catheterization
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00685447001645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00685447001645006854470016456854470016450685447001645

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
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
5144889801info@baylismedical.com

Regulatory Flags#

DUNS number
249225954
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00685447018841VersaCross Connect Transseptal DilatorVXA12-84-35-PS-D1NA2023-08-15
00685447006978Epicardial Steerable Guiding SheathESK85-35-BD-45SNA2022-07-21
00685447007623Epicardial Introducer and StyletEPI85-35-15-BSNA2022-07-21
00685447010487VersaCross Connect Transseptal DilatorVXA12-85-35-WM-D02022-05-19
00685447010531VersaCross Connect Transseptal DilatorVXA12-85-35-WM-D1NA2022-05-19
00685447010159VersaCross Steerable SheathVST00072022-05-09
00685447010166VersaCross Steerable SheathVST00092022-05-09
00685447010173VersaCross Steerable SheathVST00112022-05-09
00685447010180VersaCross Steerable SheathVST00132022-05-09
00685447010197VersaCross Steerable SheathVST00152022-05-09
00685447010203VersaCross Steerable SheathVST00172022-05-09
00685447010456SureFlex Steerable Guiding SheathTSK00072022-05-09
00685447010463SureFlex Steerable Guiding SheathTSK00092022-05-09
00685447010470SureFlex Steerable Guiding SheathTSK00112022-05-09
00685447005285TorFlex Transseptal Guiding SheathTF8-32-63-372021-11-01
00685447005292TorFlex Transseptal Guiding SheathTF8-32-63-452021-11-01
00685447005308TorFlex Transseptal Guiding SheathTF8-32-63-552021-11-01
00685447005315TorFlex Transseptal Guiding SheathTF8-32-63-902021-11-01
00685447005322TorFlex Transseptal Guiding SheathTF8-32-63-1352021-11-01
00685447005339TorFlex Transseptal Guiding SheathTF8-32-81-372021-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10801902228700ARROWTELEFLEX INCORPORATEDDYB2026-09-22
10884450489809Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489816Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489823Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489830Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489847Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489854Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489861Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489878Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489885Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489892Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489908Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489915Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489922Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489939Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489946Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489953Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489960Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489977Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489984Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450495091Hydrophilic Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450510602Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510640Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510664Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
10801902227109ARROWTELEFLEX INCORPORATEDDYB2026-09-03