FDA.reportPublic FDA data

GRAFT SIZERS

Primary DI
00384401513032
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
OTC
false
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 vascular 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
382174019
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
true
Sterilization required before use
false

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