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SVDS300 SAPHENOUS VEIN DISTENTION SYSTEM - 300mmHg

FDA UDI

Class II (US FDA UDI)

by Dmc Medical Limited

Identity

Trade Name
SVDS300 SAPHENOUS VEIN DISTENTION SYSTEM - 300mmHg FDA UDI
Generic Name
Vein irrigation/distention set FDA UDI
Device Name
Saphenous Vein Distention System - 300mmHg - Sterile FDA UDI
Model / Reference
SVDS300 FDA UDI
Description
Saphenous Vein Distention System - 300mmHg - Sterile FDA UDI

Identifiers

Catalog Number
FD-1004 FDA UDI
Primary DI / UDI-DI
05391530750066 FDA UDI
510(k) Number
K000704 FDA UDI
FDA Product Code
DWF FDA UDI
GMDN Term
Vein irrigation/distention set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4210 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Vein irrigation/distention set

SVDS300 SAPHENOUS VEIN DISTENTION SYSTEM - 300mmHg by Dmc Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vein irrigation/distention set.

Cleared under the same submission

K000704 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dmc Medical Limited

Sources (1)

  • FDA UDI 228be56c-655a-4f26-bded-e1e14af2d12d 35 fields · synced Jun 1, 2026