Zurpaz™ Steerable Sheath Set

Primary DI
05391526210048
Brand
Zurpaz™ Steerable Sheath Set
Company
CREGANNA UNLIMITED COMPANY
Model
M004EPTMCA85400
Catalog number
M004EPTMCA85400
Device description
Zurpaz™ Medium Curl, Asymmetric Curve Steerable Sheath
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131079000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131079000CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRICCreganna Medical Devices2013-08-01DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391526210048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391526210048053915262100485391526210048

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA sterile, 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), 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 of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8.5French

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985218606
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391526210017Gore TIPS® SheathTSTH1040TSTH10402016-09-23
05391526210109Lotus™ Introducer SetH749NTR180LIS-S2016-09-23
05391526210116Lotus™ Introducer SetH749NTR200LIS-L2016-09-23
25391526210028Gore TIPS SetTSET1016TSET10162016-09-23
05391526210000Gore TIPS NeedleTNDL1656TNDL16562016-09-23
05391526210031Zurpaz™ Steerable Sheath SetM004EPTMC85300M004EPTMC853002016-09-23
05391526210055Zurpaz™ Steerable Sheath SetM004USMC85100M004USMC851002016-09-23
05391526210062Zurpaz™ Steerable Sheath SetM004USMCA85200M004USMCA852002016-09-23
05391526210079Zurpaz™ Steerable Sheath SetM004JPNMC85500M004JPNMC855002016-09-23
05391526210086Zurpaz™ Steerable Sheath SetM004JPNMCA85600M004JPNMCA856002016-09-23
05391526210253Attain Assist™ CS Access Catheter 146168-01146168-012019-01-14
05391526210154Trapper™ Exchange DeviceH74939330130H749393301302017-01-27

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