Zurpaz™ Steerable Sheath Set M004USMC85100

GUDID 05391526210055

Zurpaz™ Medium Curl, Symmetric Curve Steerable Sheath

CREGANNA UNLIMITED COMPANY

Vascular guide-catheter, single-use
Primary Device ID05391526210055
NIH Device Record Key79e58dc9-d794-47a6-9614-fdefe979ebde
Commercial Distribution StatusIn Commercial Distribution
Brand NameZurpaz™ Steerable Sheath Set
Version Model NumberM004USMC85100
Catalog NumberM004USMC85100
Company DUNS985218606
Company NameCREGANNA UNLIMITED COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Device Dimensions

Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French
Catheter Gauge8.5 French

Device Identifiers

Device Issuing AgencyDevice ID
GS105391526210055 [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 Number5
Public Version Date2019-01-23
Device Publish Date2016-09-23

On-Brand Devices [Zurpaz™ Steerable Sheath Set]

05391526210086Zurpaz™ Medium Curl, Asymmetric Curve Steerable Sheath
05391526210079Zurpaz™ Medium Curl, Symmetric Curve Steerable Sheath
05391526210062Zurpaz™ Medium Curl, Asymmetric Curve Steerable Sheath
05391526210055Zurpaz™ Medium Curl, Symmetric Curve Steerable Sheath
05391526210048Zurpaz™ Medium Curl, Asymmetric Curve Steerable Sheath
05391526210031Zurpaz™ Medium Curl, Symmetric Curve Steerable Sheath

Trademark Results [Zurpaz]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZURPAZ
ZURPAZ
85522726 4716739 Live/Registered
Boston Scientific Scimed, Inc.
2012-01-23

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