← Back to catalogue

Introducer Needle

FDA UDI

Class II (US FDA UDI)

by Bard Access Systems, Inc.

Identity

Trade Name
Introducer Needle FDA UDI
Generic Name
Vascular catheter introduction needle FDA UDI
Device Name
Introducer Needle 18 ga FDA UDI
Model / Reference
5584180 FDA UDI
Description
Introducer Needle 18 ga FDA UDI

Identifiers

Catalog Number
5584180 FDA UDI
Primary DI / UDI-DI
00801741045134 FDA UDI
510(k) Number
K082580 FDA UDI
FDA Product Code
DYB FDA UDI
GMDN Term
Vascular catheter introduction needle 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
Needle Gauge — 18 Gauge FDA UDI
Length — 70 Millimeter FDA UDI

Introducer Needle by Bard Access Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K082580 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bard Access Systems, Inc.

Sources (1)

  • FDA UDI 3837ba06-1c22-42cc-b3d8-f3af4943cb09 38 fields · synced Jun 9, 2026