FDA.reportPublic FDA data

Vein Irrigation Cannula DMC VIC Sterile

Primary DI
05391530750097
Brand
Vein Irrigation Cannula DMC VIC Sterile
Company
DMC MEDICAL LIMITED
Model
DMC VIC STERILE
Catalog number
FD-1006
Device description
Vein Irrigation Cannula Sterile
Published
2016-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GBXCatheter, Irrigation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000704000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000704000DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)Dmc Medical, Ltd.2000-05-19GBX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530750103PackageGS125In Commercial Distribution
05391530750110PackageGS121In Commercial Distribution
05391530750097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530750103053915307501035391530750103
05391530750110053915307501105391530750110
05391530750097053915307500975391530750097

GMDN Terms#

Term, Definition table
TermDefinition
Vein irrigation/distention setA collection of devices used for the distention and irrigation of veins (e.g., saphenous) for testing and clearance prior to removal of a section for use as a coronary or peripheral bypass graft. It is also used for vein distention to facilitate ligating side branches in the vein. It typically consists of a standard syringe (e.g., 60 ml), various stainless steel devices (pin, spring, rod), and plastic rings and balls that are used during the process. This is a single-use device.

Regulatory Flags#

DUNS number
989772017
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391530750035SVDS200 SAPHENOUS VEIN DISTENTION SYSTEM - 200mmHgSVDS200FD-10032016-08-10
05391530750066SVDS300 SAPHENOUS VEIN DISTENTION SYSTEM - 300mmHgSVDS300FD-10042016-08-10
05391530750127Cardiac Insulation Pad Adult Sterile Adult - SterileFD-10012016-08-11
053915307501581ml Insulin Suresafe Syringe"1ml Insulin Syringe - 29G x 1/2"""FD-SSFX01L-292016-08-11
053915307501891ml Tuberculin Suresafe Syringe"1ml Tuberculin Syringe - 27G x 1/2"""FD-SSFX01L-272016-08-11
053915307502191ml Tuberculin Suresafe Syringe"1ml Tuberculin Syringe - 25G x 5/8"""FD-SSFX01T-252016-08-11
053915307502401ml Tuberculin Suresafe Syringe"1ml Tuberculin Syringe - 25G x 1"""FD-SSFX01T-25-012016-08-11
05391530750271Suresafe 1ml Syringe"1ml Syringe - 25G x 5/8"""FD-SSFX01-252016-08-11
05391530750301Suresafe 1ml Syringe"1ml Syringe - 25G x 1"""FD-SSFX01-25-012016-08-11
053915307503323ml Suresafe Syringe"3ml Syringe - 25G x 5/8"""FD-SSIC03-252016-08-12
053915307503633ml Suresafe Syringe"3ml Syringe - 25G x 1"""FD-SSIC03-25-012016-08-12
053915307503943ml Suresafe Syringe"3ml Syringe - 23G x 1"""FD-SSIC03-232016-08-12
053915307504243ml Suresafe Syringe"3ml Syringe - 23G x 1 1/2"""FD-SSIC03-23-012016-08-12
053915307504553ml Suresafe Syringe"3ml Syringe - 22G x 1 1/2"""FD-SSIC03-222016-08-12
053915307504863ml Suresafe Syringe"3ml Syringe - 21G x 1"""FD-SSIC03-212016-08-12
053915307505163ml Suresafe Syringe"3ml Syringe - 22G x 1"""FD-SSIC03-22-012016-08-12
053915307505473ml Suresafe Syringe"3ml Syringe - 21G x 1 1/2"""FD-SSIC03-21-012016-08-12
053915307505785ml Suresafe Syringe"5ml Syringe - 21G x 1 1/2"""FD-SSIC05-212016-08-12
053915307506085ml Suresafe Syringe"5ml Syringe - 22G x 1 1/2"""FD-SSIC05-222016-08-11
0539153075063910ml Suresafe Syringe"10ml Syringe - 22G x 1 1/2"""FD-SSIC10-222016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196995998MEDLINEMEDLINE INDUSTRIES, INC.GBX2024-12-12
10080196128839MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
10080196997633MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
10801902210408ARROWTELEFLEX INCORPORATEDGBX2022-11-09
10801902194005ARROWTELEFLEX INCORPORATEDGBX2022-11-08
08034139292823Thoracic Catheter, Straight Fr 18REDAX SPAGBX2021-05-07
08034139292830Thoracic Catheter, Straight Fr 21REDAX SPAGBX2021-05-07
08034139292847Thoracic Catheter, Straight Fr 24REDAX SPAGBX2021-05-07
08034139292861Thoracic Catheter, Straight Fr 30REDAX SPAGBX2021-05-07
08034139292878Thoracic Catheter, Straight Fr 33REDAX SPAGBX2021-05-07
08034139293806Thoracic Catheter, Angled Fr 30REDAX SPAGBX2021-05-07
08034139293813Thoracic Catheter, Angled Fr 33REDAX SPAGBX2021-05-07
08034139294544Flat Drain 3/4 type Jackson-Pratt 4x10 mmREDAX SPAGBX2021-05-07
08034139294568Flat Drain type Jackson-Pratt 4x10 mmREDAX SPAGBX2021-05-07
08034139294575Flat Drain type Jackson-Pratt w/trocar 4x10 mmREDAX SPAGBX2021-05-07
08034139294582Flat Drain type Jackson-Pratt 4x13 mmREDAX SPAGBX2021-05-07
08034139294599Flat Drain type Jackson-Pratt w/trocar 4x13 mmREDAX SPAGBX2021-05-07
08034139294629Round Drain type Jackson-Pratt Fr 7REDAX SPAGBX2021-05-07
08034139294643Round Drain type Jackson-Pratt Fr 10REDAX SPAGBX2021-05-07
08034139294650Round Drain type Jackson-Pratt w/trocar Fr 10REDAX SPAGBX2021-05-07
08034139294698Round Drain type Jackson-Pratt w/trocar Fr 15REDAX SPAGBX2021-05-07
08034139294933Spiral Drain Round Fluted Drain w/trocar Fr 10REDAX SPAGBX2021-05-07
08034139294940Spiral Drain Round Fluted Drain w/trocar Fr 15REDAX SPAGBX2021-05-07
08034139294964Spiral Drain Round Fluted Drain w/trocar Fr 12REDAX SPAGBX2021-05-07
08034139294971Spiral Drain Round Fluted Drain Fr 7REDAX SPAGBX2021-05-07
08034139295008Spiral Drain Round Fluted Drain Fr 10REDAX SPAGBX2021-05-07
08034139295022Spiral Drain Round Fluted Drain Fr 15REDAX SPAGBX2021-05-07
08034139295039Spiral Drain Round Fluted Drain Fr 19REDAX SPAGBX2021-05-07
08034139295053Spiral Drain Round Fluted Drain Fr 24REDAX SPAGBX2021-05-07
08034139295060Flat Fluted Drain 4x10 mmREDAX SPAGBX2021-05-07