TorFlex Transseptal Guiding Sheath

GUDID 00685447006152

TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire

Baylis Médicale Cie Inc

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use
Primary Device ID00685447006152
NIH Device Record Key8e4a668a-c042-40f6-8d32-8c8cb9978893
Commercial Distribution StatusIn Commercial Distribution
Brand NameTorFlex Transseptal Guiding Sheath
Version Model NumberTF85-32-63-45
Company DUNS249225954
Company NameBaylis Médicale Cie Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100685447006152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCatheter, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-04
Device Publish Date2021-04-26

On-Brand Devices [TorFlex Transseptal Guiding Sheath]

00685447003199TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003106TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003090TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447001645TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447001638TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447001621TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447001614TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447000822TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447000815TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447000808TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447000792TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447000785TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447000778TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447000761TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447000754TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447000747TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447000730TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447000723TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447000716TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447000709TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447000693TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447000686TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447000679TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447000662TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447000655TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447000648TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447000631TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003953TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003946TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003939TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003922TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003915TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003908TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003892TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003885TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003878TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003861TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003854TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003847TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003830TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003823TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003816TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003809TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003793TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003786TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003779TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447003762TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447006169TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire
00685447006152TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire

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