FDA.reportPublic FDA data

Vein Irrigation Cannula DMC VIC Sterile

Primary DI
05391530750110
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
Rx
false
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
989772017
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391530753944FD-1017NS - 1ml PC Syringe - White PlungerFD-1017NS -1ml PC SyringeFD-1017NS -1ml PC Syringe2026-06-03
05391530753951FD-1018NS - 1ml PC Syringe - Blue PlungerFD-1018NS - 1ml PC SyringeFD-1018NS - 1ml PC Syringe2026-06-03
05391530754217FD-1078NS 20ml PC Syringe - White Plunger - Saline PrintFD-1078NS 20ml PC SyringeFD-1078NS 20ml PC Syringe2026-06-03
05391530754620FD-1048NS 10ml PC Syringe Yellow Plunger LidocaineFD-1048NS 10ml PC Syringe Yellow PlungerFD-1048NS 10ml PC Syringe Yellow Plunger2026-06-03
05391530754699FD-1075NS 10ml PC Syringe Light Blue Plunger XylocaineFD-1075NS 10ml PC SyringeFD-1075NS 10ml PC Syringe2026-06-03
05391530754941FD-1180NS 3ml Nugen Syringe Red PlungeFD-1180NS 3ml Nugen SyringeFD-1180NS 3ml Nugen Syringe2026-06-03
05391530754965FD-1162NS 10ml Nugen Syringe Red PlungerFD-1162NS 10ml Nugen SyringeFD-1162NS 10ml Nugen Syringe2026-06-03
05391530753968FD-1019NS - 1ml PC Syringe - Yellow PlungerFD-1019NS - 1ml PC SyringeFD-1019NS - 1ml PC Syringe2026-06-02
05391530754088FD-1021NS 3ml PC Syringe White PlungerFD-1021NS 3ml PC SyringeFD-1021NS 3ml PC Syringe2026-06-02
05391530754194FD-1034NS 20ml PC Syringe Red PlungerFD-1034NS 20ml PC SyringeFD-1034NS 20ml PC Syringe2026-06-02
05391530754224FD-1033NS 20ml PC Syringe - Yellow PlungerFD-1033NS 20ml PC SyringeFD-1033NS 20ml PC Syringe2026-06-02
05391530754231FD-1092NS 20ml PC Syringe Heparin Print - Red PlungerFD-1092NS 20ml PC SyringeFD-1092NS 20ml PC Syringe2026-06-02
05391530753456FD-1032NS - 20ml PC Syringe Blue PlungerFD-1032NSFD-1032NS2026-06-01
05391530753463FD-1031NS - 20ml PC Syringe White PlungerFD-1031NSFD-1031NS2026-06-01
05391530753487FD-1113NS - 10ml PC Syringe Contrast Dark Green PlungerFD-1113NS - 10ml PC SyringeFD-1113NS - 10ml PC Syringe2026-06-01
05391530753517FD-1051NS - 10ml PC Syringe Purple Plunger - Lidocaine PrintFD-1051NS - 10ml PC SyringeFD-1051NS - 10ml PC Syringe2026-06-01
05391530753524FD-1043NS - 10ml PC Syringe - Contrast - Yellow PlungerFD-1043NS - 10ml PC SyringeFD-1043NS - 10ml PC Syringe2026-06-01
05391530753531FD-1107NS - 30ml PC Syringe - Yellow PlungerFD-1107NS - 30ml PC SyringeFD-1107NS - 30ml PC Syringe2026-06-01
05391530753548FD-1026NS - 10ml PC Syringe - White PlungerFD-1026NS - 10ml PC SyringeFD-1026NS - 10ml PC Syringe2026-06-01
05391530753555FD-1158NS - 10ml PC Syringe - Heparin/Saline White PlungerFD-1158NS - 10ml PC SyringeFD-1158NS - 10ml PC Syringe2026-06-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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