SupraCross Steerable Sheath

GUDID 00685447002574

SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire

Baylis Médicale Cie Inc

Vascular guide-catheter, single-use
Primary Device ID00685447002574
NIH Device Record Key6585af9c-76dd-4a50-b1a1-739fa925b36a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSupraCross Steerable Sheath
Version Model NumberSSS85-35-UD-45XL
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
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
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
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
GS100685447002574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-01-23
Device Publish Date2018-09-20

On-Brand Devices [SupraCross Steerable Sheath]

00685447002574SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
00685447002567SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
00685447002550SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
00685447001669SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
00685447001270SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
00685447005629SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
00685447005612SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
00685447005605SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
00685447005988SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
00685447005971SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
00685447005964SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire

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