FDA.reportPublic FDA data

Gelseal™

Primary DI
05037881100586
Brand
Gelseal™
Company
VASCUTEK LTD
Model
434022/8
Catalog number
434022/8
Device description
Gelseal Gelatin Impregnated Knitted Vascular Prosthesis ANTE-FLO
Published
2018-11-16
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
MALGRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MALGraft, Vascular, Synthetic/Biologic CompositeCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162803000
P890045001
P890045003
P890045005
P890045006

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162803000Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular GraftsVascutek, Ltd.2017-07-14DSY
P890045001GELSEAL TM TRIAXIAL VASCULAR GRAFTCarbomedics, Inc.1993-01-11MAL
P890045003GELSEAL TM TRIAXIAL VASCULAR GRAFTCarbomedics, Inc.1993-01-11MAL
P890045005GELSEAL TM TRIAXIAL VASCULAR GRAFTCarbomedics, Inc.1993-01-11MAL
P890045006GELSEAL TM TRIAXIAL VASCULAR GRAFTCarbomedics, Inc.1993-01-11MAL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05037881100586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05037881100586050378811005865037881100586

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic vascular graftA sterile 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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length40Centimeter
Lumen/Inner Diameter22Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)262-3304xx@xx.xx

Regulatory Flags#

DUNS number
229053087
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05037881184883Gelweave Vascular Prostheses73241288/10QRME73241288/10QRME2026-05-22
05037881184890Gelweave Vascular Prostheses73241288/10QRME73241288/10QRME2026-05-22
05037881184906Gelweave Vascular Prostheses73241288/10QRME73241288/10QRME2026-05-22
05037881184913Gelweave Vascular Prostheses73241288/10QRME73241288/10QRME2026-05-22
05037881184920Gelweave Vascular Prostheses73241288/10QRME73241288/10QRME2026-05-22
05037881184937Gelweave Vascular Prostheses73241288/10QRME73241288/10QRME2026-05-22
05037881026626Thoraflex™ HybridTHP2224X100ATHP2224X100A2022-05-31
05037881026695Thoraflex™ HybridTHP2426X100ATHP2426X100A2022-05-31
05037881026725Thoraflex™ HybridTHP3032X100ATHP3032X100A2022-05-31
05037881026756Thoraflex™ HybridTHP3038X100ATHP3038X100A2022-05-31
05037881026800Thoraflex™ HybridTHP2628X150ATHP2628X150A2022-05-31
05037881026848Thoraflex™ HybridTHP3036X150ATHP3036X150A2022-05-31
05037881026923Thoraflex™ HybridTHA2830X100ATHA2830X100A2022-05-31
05037881026947Thoraflex™ HybridTHA3034X100ATHA3034X100A2022-05-31
05037881027029Thoraflex™ HybridTHA2830X150ATHA2830X150A2022-05-31
05037881027067Thoraflex™ HybridTHA3038X150ATHA3038X150A2022-05-31
05037881027074Thoraflex™ HybridTHA3040X150ATHA3040X150A2022-05-31
05037881031712Thoraflex™ HybridTHP2224X100BTHP2224X100B2025-09-04
05037881031729Thoraflex™ HybridTHP2426X100BTHP2426X100B2025-09-04
05037881031736Thoraflex™ HybridTHP2628X100BTHP2628X100B2025-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840663110353AlboGraft Polyester Vascular GraftLemaitre Vascular, Inc.MAL2021-06-18
00840663110360AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2021-06-18
00840663110377AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2021-06-18
00840663110384AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2021-06-18
00840663110391AlboGraft Polyester Vascular GraftLemaitre Vascular, Inc.MAL2021-06-18
00840663110407AlboGraft Polyester Vascular GraftLemaitre Vascular, Inc.MAL2021-06-18
00840663110414AlboGraft Polyester Vascular GraftLemaitre Vascular, Inc.MAL2021-06-18
00840663110421AlboGraft Polyester Vascular GraftLemaitre Vascular, Inc.MAL2021-06-18
00840663110438AlboGraft Polyester Vascular GraftLemaitre Vascular, Inc.MAL2021-06-18
00840663110445AlboGraft Polyester Vascular GraftLemaitre Vascular, Inc.MAL2021-06-18
00840663107384AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-12-29
00840663107407AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-12-29
00840663103935AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663103942AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663103959AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663103966AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663103973AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663103980AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663103997AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104000AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104017AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104024AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104031AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104048AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104055AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104062AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104079AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104086AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104093AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09
00840663104109AlboGraft Polyester Vascular Graft Lemaitre Vascular, Inc.MAL2015-11-09