AuST Steerable Sheath

Primary DI
00810024670840
Brand
AuST Steerable Sheath
Company
CENTERPOINT SYSTEMS LLC
Model
0-132H-S3574SAN0-SNST0
Published
2025-02-03
Public version status
New
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
DRACatheter, Steerable
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRACatheter, SteerableCardiovascular2
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242106000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242106000AuST Steerable SheathCenterPoint Systems, LLC2024-10-04DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810024670840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810024670840008100246708408100246708400810024670840

GMDN Terms#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117126091
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810024672134CPS Locator 3D, BB1-36DS2CBB1-36DS2CBB1-362026-03-30
00810024672141CPS Locator 3D, BB1-40DS2CBB1-40DS2CBB1-402026-03-30
00810024671991AuST Steerable Sheath0-132H-H3574SAN0-SNSP02026-01-29
00810024672004AuST Steerable Sheath0-132H-H5074SAN0-SNSP02026-01-29
00810024670314AuST Steerable Sheath0-120H-H1774SAN5-SNSP02026-01-12
00810024670536AuST Steerable Sheath0-085H-H1774SAN0-SNSP02026-01-12
00810024670543AuST Steerable Sheath0-085H-H2274SAN0-SNSP02026-01-12
00810024670550AuST Steerable Sheath0-085H-H5074SAN0-SNSP02026-01-12
00810024671724DF4 Helix Locking ToolA002HELX2025-12-03
00810024671342AuST Steerable Sheath0-085H-H1744SAN0-SNSP02025-11-05
00810024671359AuST Steerable Sheath0-085H-H2244SAN0-SNSP02025-11-05
00810024671366AuST Steerable Sheath0-085H-H3544SAN0-SNSP02025-11-05
00810024671373AuST Steerable Sheath0-085H-H5044SAN0-SNSP02025-11-05
00810024671380AuST Steerable Sheath0-132H-H3544SAN0-SNSP02025-11-05
00810024671397AuST Steerable Sheath0-132H-H5044SAN0-SNSP02025-11-05
00810024671403AuST Steerable Sheath0-085H-S1765SAN0-SNSP02025-11-05
00810024671410AuST Steerable Sheath0-120H-H1765SAN0-SNSP02025-11-05
00810024671427AuST Steerable Sheath0-120H-H2265SAN0-SNSP02025-11-05
00810024671434AuST Steerable Sheath0-120H-H3565SAN0-SNSP02025-11-05
00810024671441AuST Steerable Sheath0-132H-H3565SAN0-SNSP02025-11-05

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