FDA.reportPublic FDA data

Site~Rite 8 Ultrasound System

Primary DI
00801741138263
Brand
Site~Rite 8 Ultrasound System
Company
Bard Access Systems, Inc.
Model
9770600
Catalog number
9770600
Device description
Site~Rite 8 Ultrasound System Console
Published
2018-01-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYOSystem, imaging, pulsed echo, ultrasonic
LLZSystem, image processing, radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741138263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741138263008017411382638017411382630801741138263

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)545-0890medical.services@crbard.com

Regulatory Flags#

DUNS number
044611812
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741240034PowerPICC SOLOCK001093CK0010932026-05-27
00801741240041PowerPICC Provena SOLOCK001094CK0010942026-05-27
00801741240058PowerPICC Provena SOLOCK001095CK0010952026-05-27
00801741240065PowerPICC Provena SOLO Catheter with Sherlock 3CGCK001096CK0010962026-05-27
00801741240072PowerPICC Provena SOLO Catheter with Sherlock 3CGCK001097CK0010972026-05-27
10801741082983StatLockS04020010S040200102025-05-02
10801741087582StatLockD05000002AD05000002A2025-05-02
10801741188852StatLockSEC2404320SEC24043202020-04-22
10801741188869StatLockSEC2404321SEC24043212020-04-22
00801741075452SecurisSEC0100SEC01002019-10-17
00801741081248StatLock068400047206840004722025-05-02
00801741081255StatLock068400049306840004932025-05-02
00801741081521STATLOCKCV0223CV02232023-11-09
00801741081552STATLOCKCV0226CV02262023-11-09
00801741081576STATLOCKCV0321CV03212023-11-09
00801741081675STATLOCKIB0200IB02002023-11-09
00801741081682STATLOCKIV0220IV02202023-11-09
00801741081750STATLOCKIV0500IV05002023-11-09
00801741081767STATLOCKIV0501IV05012023-11-09
00801741081897STATLOCKIV0528IV05282023-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
M722CD26127V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-05-28
17540262200096Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-05-27
75401622522101Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-05-27
08437021722093ADAS 3DADAS3D MEDICAL S.L.LLZ2026-05-12
08033837938835no brandCEFLA SOCIETA' COOPERATIVALLZ2026-05-11
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08800066200619JLK-AILINKJLK, Inc.LLZ2026-03-25
08800066200787JLK-CTPJLK, Inc.LLZ2026-03-25
08800066200794JLK-PWIJLK, Inc.LLZ2026-03-25
08056304455826MyLabC25ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAIYO2025-12-10
08056304455017MyLabA50ESAOTE SPAIYO2025-07-07
08056304455215MyLabE85ESAOTE SPAIYO2025-07-07
08056304455307MyLabA70ESAOTE SPAIYO2025-07-07
08056304455437MyLabA50ESAOTE SPAIYO2025-07-07
08056304455451MyLabA70ESAOTE SPAIYO2025-07-07
08056304455635MyLabE80ESAOTE SPAIYO2025-07-07
08056304455642MyLabE85ESAOTE SPAIYO2025-07-07
08437021468175QP-ProstateQUIBIM SOCIEDAD LIMITADA.LLZ2025-07-04
08800026700869Medit Orthodontic SuiteMedit Corp.LLZ2025-05-29
088000186022562430TCARayence Co., Ltd.LLZ2025-04-08
07630542730153MyShoulder PlannerMedacta International SALLZ2025-02-06
07613252286578FLUOROMAPStryker Leibinger GmbH & Co. KGLLZ2025-01-28
07613252286622FLUOROMAPStryker Leibinger GmbH & Co. KGLLZ2025-01-28