FDA.reportPublic FDA data

Sublime™ Radial Access Guide Sheath

Primary DI
05391525785165
Brand
Sublime™ Radial Access Guide Sheath
Company
CREAGH MEDICAL LIMITED
Model
SRA-GS35-6F120
Published
2020-12-07
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
K190644000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190644000Guide SheathSurmodics,Inc.2019-04-18DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391525785165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391525785165053915257851655391525785165

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length120Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985021909
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391525787480Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation CatheterSER18-135-50-2202025-03-14
05391525787497Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation CatheterSER18-135-60-2202025-03-14
05391525787503Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation CatheterSER18-135-70-2202025-03-14
05391525785912Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-200202021-10-20
05391525785929Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-200402021-10-20
05391525785936Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-200602021-10-20
05391525785943Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-200802021-10-20
05391525785950Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-201002021-10-20
05391525785967Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-201202021-10-20
05391525785974Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-201502021-10-20
05391525785981Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-202202021-10-20
05391525785998Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-250202021-10-20
05391525786001Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-250402021-10-20
05391525786018Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-250602021-10-20
05391525786025Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-250802021-10-20
05391525786032Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-251002021-10-20
05391525786049Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-251202021-10-20
05391525786056Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-251502021-10-20
05391525786063Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-252202021-10-20
05391525786070Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-300202021-10-20

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Primary DI, Brand, Company table
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