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Site~Rite 8 Ultrasound System

FDA UDI

Class II (US FDA UDI)

by Bard Access Systems, Inc.

Identity

Trade Name
Site~Rite 8 Ultrasound System FDA UDI
Generic Name
Ultrasound imaging system operator console FDA UDI
Device Name
Site~Rite 8 Ultrasound System Console (Remanufactured) FDA UDI
Model / Reference
9770600Y FDA UDI
Description
Site~Rite 8 Ultrasound System Console (Remanufactured) FDA UDI

Identifiers

Catalog Number
9770600Y FDA UDI
Primary DI / UDI-DI
00801741138287 FDA UDI
FDA Product Code
IYO FDA UDI
LLZ FDA UDI
GMDN Term
Ultrasound imaging system operator console FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1560 FDA UDI
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ultrasound imaging system operator console

Site~Rite 8 Ultrasound System by Bard Access Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasound imaging system operator console.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bard Access Systems, Inc.

Sources (1)

  • FDA UDI cd784dd4-54cf-4347-800f-2d1757c816ee 35 fields · synced Jun 9, 2026