FDA.report

Distaflo® Bypass Grafts

Primary DI
00801741023552
Brand
Distaflo® Bypass Grafts
Company
Bard Peripheral Vascular, Inc.
Model
DF6008SC
Catalog number
DF6008SC
Device description
Distaflo® Bypass Graft With Flex Small Beading Standard Cuff, 8 mm x 60 cm
Published
2015-04-13
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
DYFPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER

Product Code Classifications

CodeDeviceSpecialtyClass
DYFProsthesis, Vascular Graft, Of Less Then 6mm DiameterCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00801741023552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741023552008017410235528017410235520801741023552

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
Length60Centimeter

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

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Primary DIBrandCompanyProduct codePublished
00818136020539exGraftPECA LABS, INC.DYF2024-12-04
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00818136022762exGraftPECA LABS, INC.DYF2024-12-04
00818136022373exGraftPECA LABS, INC.DYF2024-12-04
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