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Introducer set with hemostatic valve

FDA UDI

Class II (US FDA UDI)

by Oscor Inc.

Identity

Trade Name
Introducer set with hemostatic valve FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Device Name
Introducer set with hemostatic valve, 4F FDA UDI
Model / Reference
DYNJINTROR4 FDA UDI
Description
Introducer set with hemostatic valve, 4F FDA UDI

Identifiers

Catalog Number
DYNJINTROR4 FDA UDI
Primary DI / UDI-DI
40888277000699 FDA UDI
510(k) Number
K130633 FDA UDI
FDA Product Code
DYB FDA UDI
GMDN Term
Vascular catheter introduction set, nonimplantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 FDA UDI
Commercial Distribution
Not 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

Yes

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

No

FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 1.5 Millimeter FDA UDI

Introducer set with hemostatic valve by Oscor Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K130633 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oscor Inc.

Sources (1)

  • FDA UDI c32b9806-5f4d-4021-8527-b9957c48a02a 39 fields · synced May 31, 2026