PREFACE

Primary DI
10846835000030
Brand
PREFACE
Company
Biosense Webster Inc
Model
301803MS
Catalog number
301803MS
Device description
PREF GUIDING SHEATH:MULTI-SHRT
Published
2016-09-16
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982740000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982740000CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813SCordis Webster, Inc.1998-08-28DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10846835000030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084683500003010846835000030

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged
Special Storage Condition, Specify00Do not use if package is opened
Special Storage Condition, Specify00Keep Dry
Special Storage Condition, Specify00Keep out of direct sunlight
Special Storage Condition, Specify00Store in cool, dark, dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)729-9010RA-BWIUS-Complaints@its.jnj.com

Regulatory Flags#

DUNS number
020163218
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10846835009798THERMOCOOL SMARTTOUCH SFD134703D1347032016-11-11
10846835010121Sterile Interface CableD133701D1337012024-12-11
10846835016796TX eco EXT CableD135703D1357032023-10-04
10846835025811OPTRELL Mapping Catheter with TRUEref TechnologyD142902D1429022023-10-04
10846835025828OPTRELL Mapping Catheter with TRUEref TechnologyD142901D1429012023-10-04
10846835017427TX eco CableD140102D1401022023-07-21
10846835016710QDOT MICROD139501D1395012023-07-07
10846835016727QDOT MICROD139502D1395022023-07-07
10846835016734QDOT MICROD139503D1395032023-07-07
10846835016741QDOT MICROD139504D1395042023-07-07
10846835016758QDOT MICROD139505D1395052023-07-07
10846835017045QDOT MICROD139401D1394012023-07-07
10846835017076QDOT MICROD139402D1394022023-07-07
10846835017106QDOT MICROD139403D1394032023-07-07
10846835021110OCTARAY Mapping CatheterD160902D1609022021-10-14
10846835021127OCTARAY Mapping CatheterD160903D1609032021-10-14
10846835021134OCTARAY Mapping CatheterD160906D1609062021-10-14
10846835021141OCTARAY Mapping CatheterD160901D1609012021-10-14
10846835021158OCTARAY Mapping CatheterD160905D1609052021-10-14
10846835021233OCTARAY Mapping CatheterD160904D1609042021-10-14

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