FDA.reportPublic FDA data

GRAFT SIZERS

Primary DI
00384401016502
Brand
GRAFT SIZERS
Company
INTERVASCULAR SAS
Model
Size 05 mm - 24 mm
Device description
Graft Sizers size 05 mm - 24 mm are commercially available only in Multipack configuration (box of 10 units) with the catalog number M002363200201.
Published
2016-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSYProsthesis, Vascular Graft, Of 6mm And Greater DiameterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K854431000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K854431000MEADOX MEDICALS INC. GRAFT SIZERMeadox Medicals, Div. Boston Scientific Corp.1986-05-07DSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00384401513032PackageGS110In Commercial Distribution
00384401016502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00384401513032003844015130323844015130320384401513032
00384401016502003844010165023844010165020384401016502

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery blood vessel sizer, single-useA sterile, invasive instrument intended to be used during open vascular surgery to approximate the size of a blood vessel for selection of an appropriately sized vascular device/implant (e.g., vascular graft, emboli filter); it is not intended to obtain a precise measurement. The device typically consists of a C-shaped (half circle) sizing portion with a handle, sometimes available in a range of sizes, and is intended to size the outer diameter of the blood vessel (i.e., extraluminal sizing); it may in addition be used to size a vascular graft. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at controlled room temperature

Contacts#

Phone, Email table
PhoneEmail
+33442084646cardiovascular.vics@getinge.com

Regulatory Flags#

DUNS number
382174019
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00384401006466IntergardIGKUT0008RS15IGKUT0008RS152023-03-27
00384401007067IntergardIGKUT0006-20IGKUT0006-202023-03-27
00384401007609IntergardIGKUT0008-20IGKUT0008-202023-03-27
00384401009252IntergardIGKUT0007-20IGKUT0007-202023-03-27
00384401000013IntergardIGW0006-30IGW0006-302015-09-25
00384401000037IntergardIGW0008-30IGW0008-302015-09-25
00384401000051IntergardIGW0010-30IGW0010-302015-09-25
00384401000075IntergardIGW0012-15IGW0012-152015-09-25
00384401000082IntergardIGW0012-30IGW0012-302015-09-25
00384401000099IntergardIGW0014-15IGW0014-152015-09-25
00384401000105IntergardIGW0014-30IGW0014-302015-09-25
00384401000112IntergardIGW0016-15IGW0016-152015-09-25
00384401000129IntergardIGW0016-30IGW0016-302015-09-25
00384401000136IntergardIGW0018-15IGW0018-152015-09-25
00384401000143IntergardIGW0018-30IGW0018-302015-09-25
00384401000150IntergardIGW0020-15IGW0020-152015-09-25
00384401000167IntergardIGW0020-30IGW0020-302015-09-25
00384401000174IntergardIGW0022-15IGW0022-152015-09-25
00384401000181IntergardIGW0022-30IGW0022-302015-09-25
00384401000198IntergardIGW0024-15IGW0024-152015-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00733132600038GORE Hybrid Vascular Graft-CBASW. L. Gore & Associates, Inc.DSY2017-02-13
00733132600052GORE Hybrid Vascular Graft-CBASW. L. Gore & Associates, Inc.DSY2017-02-13
00733132600076GORE Hybrid Vascular Graft-CBASW. L. Gore & Associates, Inc.DSY2017-02-13
00733132600090GORE Hybrid Vascular Graft-CBASW. L. Gore & Associates, Inc.DSY2017-02-13
00733132605354GORE ACUSEAL Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606290GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606313GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606351GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606375GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606399GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606436GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607068GORE PROPATEN Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607129GORE PROPATEN Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607143GORE PROPATEN Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607150GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607174GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607181GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607211GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607228GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607235GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607242GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607259GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607266GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607273GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607280GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607297GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607303GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132611508GORE-TEX Stretch Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132611539GORE-TEX Stretch Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132611546GORE-TEX Stretch Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13