FDA.reportPublic FDA data

GORE VIATORR TIPS Endoprosthesis

Primary DI
00733132609796
Brand
GORE VIATORR TIPS Endoprosthesis
Company
W. L. Gore & Associates, Inc.
Model
PTB104275
Catalog number
PTB104275
Device description
VIATORR ENDOPROTHESIS 10MMX4/2CM VIATORR
Published
2017-02-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MIRShunt, Portosystemic, Endoprosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIRShunt, Portosystemic, EndoprosthesisUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P040027033

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040027033GORE VIATORR TIPSW. L. Gore & Associates, Inc.2004-12-06MIR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733132609796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132609796007331326097967331326097960733132609796

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Centimeter
Outer Diameter10Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8005288763mpdcustomercare@wlgore.com

Regulatory Flags#

DUNS number
967358115
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00733132612147GORE DrySeal SheathSDV1828SDV18282017-02-13
00733132644773GORE SEAMGUARD Bioabsorbable Staple Line Reinforce20055724200557242018-08-31
00733132644780GORE SEAMGUARD Bioabsorbable Staple Line Reinforce20055721200557212018-08-31
00733132658855GORE® DrySeal Flex Introducer SheathGDSF1033GDSF10332024-12-02
00733132658862GORE® DrySeal Flex Introducer SheathGDSF1045GDSF10452024-12-02
00733132658879GORE® DrySeal Flex Introducer SheathGDSF1065GDSF10652024-12-02
00733132658886GORE® DrySeal Flex Introducer SheathGDSF1133GDSF11332024-12-02
00733132658893GORE® DrySeal Flex Introducer SheathGDSF1233GDSF12332024-12-02
00733132658909GORE® DrySeal Flex Introducer SheathGDSF1245GDSF12452024-12-02
00733132658916GORE® DrySeal Flex Introducer SheathGDSF1265GDSF12652024-12-02
00733132658923GORE® DrySeal Flex Introducer SheathGDSF1433GDSF14332024-12-02
00733132658930GORE® DrySeal Flex Introducer SheathGDSF1465GDSF14652024-12-02
00733132658947GORE® DrySeal Flex Introducer SheathGDSF1533GDSF15332024-12-02
00733132658954GORE® DrySeal Flex Introducer SheathGDSF1633GDSF16332024-12-02
00733132658961GORE® DrySeal Flex Introducer SheathGDSF1665GDSF16652024-12-02
00733132658978GORE® DrySeal Flex Introducer SheathGDSF1833GDSF18332024-12-02
00733132658985GORE® DrySeal Flex Introducer SheathGDSF1865GDSF18652024-12-02
00733132658992GORE® DrySeal Flex Introducer SheathGDSF2033GDSF20332024-12-02
00733132659005GORE® DrySeal Flex Introducer SheathGDSF2065GDSF20652024-12-02
00733132659012GORE® DrySeal Flex Introducer SheathGDSF2233GDSF22332024-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00801741235979LivertyAngiomed GmbH & Co. Medizintechnik KGMIR2026-10-07
00801741235986LivertyAngiomed GmbH & Co. Medizintechnik KGMIR2026-10-07
00801741235993LivertyAngiomed GmbH & Co. Medizintechnik KGMIR2026-10-07
00801741236006LivertyAngiomed GmbH & Co. Medizintechnik KGMIR2026-10-07
00801741236013LivertyAngiomed GmbH & Co. Medizintechnik KGMIR2026-10-07
00801741236020LivertyAngiomed GmbH & Co. Medizintechnik KGMIR2026-10-07
00801741236105LivertyAngiomed GmbH & Co. Medizintechnik KGMIR2026-10-07
00733132664177GORE® VIATORR® TIPS Endoprosthesis with Controlled ExpansionW. L. Gore & Associates, Inc.MIR2025-10-29
00733132664184GORE® VIATORR® TIPS Endoprosthesis with Controlled ExpansionW. L. Gore & Associates, Inc.MIR2025-10-29
00733132664191GORE® VIATORR® TIPS Endoprosthesis with Controlled ExpansionW. L. Gore & Associates, Inc.MIR2025-10-29
00733132664207GORE® VIATORR® TIPS Endoprosthesis with Controlled ExpansionW. L. Gore & Associates, Inc.MIR2025-10-29
00733132664214GORE® VIATORR® TIPS Endoprosthesis with Controlled ExpansionW. L. Gore & Associates, Inc.MIR2025-10-29
00733132609741GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609758GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609765GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609772GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609789GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
H373PTB0842753GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
H373PTB0852753GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
H373PTB0862753GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
H373PTB0872753GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
H373PTB0882753GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609802GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609819GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609826GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609833GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609840GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609857GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609864GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132635009GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2016-12-13