FDA.report

IMPRA® ePTFE Vascular Grafts

Primary DI
00801741023316
Brand
IMPRA® ePTFE Vascular Grafts
Company
Bard Peripheral Vascular, Inc.
Model
F70T74TW
Catalog number
F70T74TW
Device description
IMPRA® ePTFE Vascular Graft, Flex™ Thinwall Tapered, 7-4 mm x 70 cm
Published
2015-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Product Code Classifications

CodeDeviceSpecialtyClass
DSYProsthesis, Vascular Graft, Of 6mm And Greater DiameterCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00801741023316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741023316008017410233168017410233160801741023316

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Length70Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags

DUNS number
135057938
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00801741234187EnCor EnCompass™ENCPBagENCPBag2026-02-09
10801741234153EnCor EnCompass™ENCPSCENCPSC2026-02-04
10801741234160EnCor EnCompass™ENCPMRIXENCPMRIX2026-02-04
00801741236167EnCor EnCompass™ENCP10GVLOCENCP10GVLOC2026-02-04
00801741234194EnCor EnCompass™ENCPSTENCPST2026-02-03
00801741234248EnCor EnCompass™ENCPDriverENCPDriver2026-02-03
00801741234262EnCor EnCompass™ENCPFSENCPFS2026-02-03
00801741235221EnCor EnCompass™ENCPConsoleENCPConsole2026-02-03
10801741234092EnCor EnCompass™ENCP7GENCP7G2026-01-30
10801741234139EnCor EnCompass™ENCP7GBTENCP7GBT2026-01-30
00801741234200EnCor EnCompass™ENCP7GVLOCENCP7GVLOC2026-01-30
10801741234115EnCor EnCompass™ENCP12GENCP12G2026-01-28
10801741234146EnCor EnCompass™ENCP10GBTENCP10GBT2026-01-28
10801741234177EnCor EnCompass™ENCP10GENCP10G2026-01-28
10801741226332UltraCor™ Twirl™UCLS17UCLS172025-04-01
10801741226349UltraCor™ Twirl™UCVR17UCVR172025-04-01
10801741230605PeritX90-201090-20102025-01-23
10801741230612PeritX90-200590-20052025-01-23
10801741230636PeritX90-202090-20202025-01-23
50885403464032JamshidiEJC3513EJC35132017-10-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05037881184883Gelweave Vascular ProsthesesVASCUTEK LTDDSY2026-05-22
05037881184890Gelweave Vascular ProsthesesVASCUTEK LTDDSY2026-05-22
05037881184906Gelweave Vascular ProsthesesVASCUTEK LTDDSY2026-05-22
05037881184913Gelweave Vascular ProsthesesVASCUTEK LTDDSY2026-05-22
05037881184920Gelweave Vascular ProsthesesVASCUTEK LTDDSY2026-05-22
05037881184937Gelweave Vascular ProsthesesVASCUTEK LTDDSY2026-05-22
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
05037881166773Gelsoft Plus Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881166827Gelsoft Plus Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881166919Gelsoft Plus Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881166964Gelsoft Plus Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881166988Gelsoft Plus Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881167015Gelsoft Plus Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881167053Gelsoft Plus Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881168609Gelweave Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881168661Gelweave Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881168753Gelweave Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881168791Gelweave Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881168814Gelweave Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881168951Gelweave Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881168999Gelweave Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881169019Gelweave Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881169187Gelweave Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881169194Gelweave Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881169248Gelweave Vascular ProsthesesVASCUTEK LTDDSY2025-05-13
05037881169262Gelweave Vascular ProsthesesVASCUTEK LTDDSY2025-05-13