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Site-Rite

FDA UDI

Class II (US FDA UDI)

by Bard Access Systems, Inc.

Identity

Trade Name
Site-Rite FDA UDI
Generic Name
Needle guide, single-use FDA UDI
Device Name
20 GA N.G. KIT, 10 PACK FDA UDI
Model / Reference
9001C0214 FDA UDI
Description
20 GA N.G. KIT, 10 PACK FDA UDI

Identifiers

Catalog Number
9001C0214 FDA UDI
Primary DI / UDI-DI
00801741037825 FDA UDI
FDA Product Code
ITX FDA UDI
GMDN Term
Needle guide, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Dimensions & Sizes

Size
Needle Gauge — 20 Gauge FDA UDI
Length — 48 Inch FDA UDI

Category: Needle guide, single-use

Site-Rite by Bard Access Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Needle guide, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI ab2298ef-d3f3-4a0f-a651-95b250c61f56 36 fields · synced Jun 9, 2026