FDA.reportPublic FDA data

Vein Irrigation Cannula

Primary DI
05391530750097
Brand
Vein Irrigation Cannula
Company
DMC MEDICAL LIMITED
Model
Vein Irrigation Cannula 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.

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
05391530753982polycarbonate syringesFD-1095NS - 1ml PC Syringe Dark Green Plunger 1ml FD-1095NS - 1ml PC Syringe Dark Green Plunger 1ml 2026-10-01
05391530753999polycarbonate syringesFD-1094NS - 1ml PC Syringe Light Green Plunger 1mlFD-1094NS - 1ml PC Syringe Light Green Plunger 1ml2026-10-01
05391530754408polycarbonate syringesFD-1076NS 10ml PC Syringe Light Blue Flush PrintFD-1076NS 10ml PC Syringe Light Blue Flush Print2026-10-01
05391530754439polycarbonate syringes10ml PC Syringe Light Blue Plunger Saline Print10ml PC Syringe Light Blue Plunger Saline Print2026-10-01
05391530754750polycarbonate syringesFD-1116NS 10ml PC Syringe White Plunger Nitro PrinFD-1116NS 10ml PC Syringe White Plunger Nitro Prin2026-10-01
05391530754798polycarbonate syringesFD-1120NS 10ml PC Syringe Light Green Plunger SaliFD-1120NS 10ml PC Syringe Light Green Plunger Sali2026-10-01
05391530755351polycarbonate syringesFD-1190NS 10ml Nugen Syringe Yellow Plunger Non-StFD-1190NS 10ml Nugen Syringe Yellow Plunger Non-St2026-10-01
05391530754033Polycarbonate SyringeFD-1098NS 3ml PC Syringe Dark Green PlungerFD-1098NS 3ml PC Syringe Dark Green Plunger2026-09-27
05391530754057Polycarbonate SyringeFD-1097NS 3ml PC Syringe Light Green PlungerFD-1097NS 3ml PC Syringe Light Green Plunger2026-09-27
05391530754118Polycarbonate SyringeFD-1068NS 3ml PC Syringe Red Plunger Nitro PrintFD-1068NS 3ml PC Syringe Red Plunger Nitro Print2026-09-27
05391530754149polycarbonate syringe6ml PC Syringe Light Green Plunger - Non-Sterile6ml PC Syringe Light Green Plunger - Non-Sterile2026-09-27
05391530754170polycarbonate syringeFD-1099NS 6ml PC Syringe Yellow PlungerFD-1099NS 6ml PC Syringe Yellow Plunger2026-09-27
05391530754255polycarbonate syringeFD-1105NS 20ml PC Syringe with Dark Green PlungerFD-1105NS 20ml PC Syringe with Dark Green Plunger2026-09-27
05391530754279polycarbonate syringe20ml PC Syringe Light Blue Plunger HEPARIN/SALINE 20ml PC Syringe Light Blue Plunger HEPARIN/SALINE 2026-09-27
05391530754286polycarbonate syringeFD-1104NS 20ml PC Syringe with Light Green PlungerFD-1104NS 20ml PC Syringe with Light Green Plunger2026-09-27
05391530754323polycarbonate syringe30ml PC Syringe White Plunger30ml PC Syringe White Plunger2026-09-27
05391530754385polycarbonate syringesFD-1079NS 10ml PC Syringe Purple Plunger Heparin PFD-1079NS 10ml PC Syringe Purple Plunger Heparin P2026-09-27
05391530754415polycarbonate syringeFD-1037NS 10ml PC Syringe Light Blue Plunger HeparFD-1037NS 10ml PC Syringe Light Blue Plunger Hepar2026-09-27
05391530754477polycarbonate syringeFD-1041NS 10ml PC Syringe Light Green Plunger HepaFD-1041NS 10ml PC Syringe Light Green Plunger Hepa2026-09-27
05391530754484polycarbonate syringe10ml PC Syringe Light Green Plunger Lidocaine Prin10ml PC Syringe Light Green Plunger Lidocaine Prin2026-09-27

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