FDA.report

Gelsoft Plus Vascular Prostheses

Primary DI
05037881166919
Company
VASCUTEK LTD
Model
631206PE
Catalog number
631206PE
Device description
Gelsoft Plus Bifurcate
Published
2025-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
229053087
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Identifiers

IdentifierTypeAgencyPackage quantityStatus
05037881166919PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
05037881166919PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter2Cardiovascular870.3450YEligible

Premarket Submissions

SubmissionSupplement
K241070000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K241070000Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.2024-11-15DSY

GMDN Terms

TermDefinition
Synthetic vascular graftAn implantable artificial substitute for a blood vessel intended to replace or bypass the diseased or injured vessel. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics and is best suited for large (more than 10 mm) diameter, high-flow vessel replacement (e.g., aortic or aorto-iliac artery reconstruction) and also for haemodialysis access and extra-anatomic bypass grafting. The device is used in many vascular bypass procedures (e.g., aorto-iliac, femoral-popliteal, axillo-axillary artery) except those involving the coronary arteries.

Device Sizes

No records found.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius35 Degrees Celsius

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+44441418125555tmccustomer.admin@terumomedical.com

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05037881031736Thoraflex™ HybridTHP2628X100BTHP2628X100B2025-09-04
05037881031743Thoraflex™ HybridTHP2830X100BTHP2830X100B2025-09-04
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05037881031774Thoraflex™ HybridTHP3036X100BTHP3036X100B2025-09-04
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05037881031804Thoraflex™ HybridTHP3240X100BTHP3240X100B2025-09-04
05037881031811Thoraflex™ HybridTHP2224X150BTHP2224X150B2025-09-04
05037881031828Thoraflex™ HybridTHP2426X150BTHP2426X150B2025-09-04
05037881031835Thoraflex™ HybridTHP2628X150BTHP2628X150B2025-09-04
05037881031842Thoraflex™ HybridTHP2830X150BTHP2830X150B2025-09-04
05037881031859Thoraflex™ HybridTHP3032X150BTHP3032X150B2025-09-04
05037881031866Thoraflex™ HybridTHP3034X150BTHP3034X150B2025-09-04
05037881031873Thoraflex™ HybridTHP3036X150BTHP3036X150B2025-09-04
05037881031880Thoraflex™ HybridTHP3038X150BTHP3038X150B2025-09-04
05037881031897Thoraflex™ HybridTHP3040X150BTHP3040X150B2025-09-04
05037881031903Thoraflex™ HybridTHP3240X150BTHP3240X150B2025-09-04

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Primary DIBrandCompanyProduct codePublished
05037881114040Gelweave Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881114057Gelweave Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881166506Gelsoft Plus Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881166513Gelsoft Plus Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881166759Gelsoft Plus Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
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05037881166827Gelsoft Plus Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881166964Gelsoft Plus Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
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05037881169019Gelweave Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881169187Gelweave Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881169194Gelweave Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
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05037881169385Gelweave Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881169392Gelweave Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881169590Gelweave Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881169637Gelweave Vascular ProsthesesVASCUTEK LTDDSY2025-05-13