FDA.reportPublic FDA data

ADVANCED TABLE, OPERATING-ROOM, NON-ELECTRICAL

Primary DI
B510OT30K0
Brand
ADVANCED TABLE, OPERATING-ROOM, NON-ELECTRICAL
Company
ADVANCED INSTRUMENTATIONS, INC.
Model
OT-30 K
Published
2020-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FWYTable, Operating-Room, Non-Electrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWYTable, Operating-Room, Non-ElectricalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B510OT30K0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic operating table, hydraulicA mobile table powered by manually-operated hydraulic mechanisms designed to support a patient and to provide traction for the limb(s) of the patient (upper or lower extremity) during orthopaedic surgical procedures. Its surface consists of sections that can be height-adjusted in relation to the section supporting the patient's trunk, and the sections that initially support the legs which are lowered once the patient has been placed in traction. Broken bones can be drawn apart, repositioned, and set to the correct position.

Regulatory Flags#

DUNS number
608736880
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B510SL700700LED1ADVANCED SURGICAL LAMP SL700/700 LED2026-03-24
D510DUS6000ADVANCED DIGITAL PORTABLE ULTRASONIC SYSTEM DUS-60002026-03-24
B510D100ADVANCED MONITOR DEFIBRILLATORD100+2026-01-14
B510PT3000ADVANCED PHOTOTHERAPY LAMP PT-30002025-08-21
B510PM200MPRO1ADVANCED PATIENT MONITORPM-200M PRO2025-07-23
B510V1000ADVANCED VENTILATORV-10002025-02-10
B510A31860ADVANCED NEONATAL INCUBATORA31862025-02-07
B510A31861ADVANCED NEONATAL INCUBATORA3186+2025-02-07
B510A4051ADVANCED INFANT WARMERA40512025-02-07
B510AM60001ADVANCED GAS-MACHINE ANESTHESIAAM-6000+2025-02-07
B510FM9000ADVANCED FETAL MONITORFM-90002025-02-07
B510PT2000ADVANCED LED PHOTOTHERAPY LAMPPT-20002025-02-07
B510PT5000ADVANCED LED PHOTOTHERAPY LAMPPT-50002025-02-07
B510A3158ADVANCED TRANSPORT INCUBATORA31582025-02-04
B510IP200ADVANCED INFUSION PUMPIP-2002025-02-04
B510PMMAX13ADVANCED PATIENT MONITORPM-Max132024-12-19
B510PMMAX15ADVANCED PATIENT MONITORPM-Max152024-12-19
B510PM2000A1ADVANCED PATIENT MONITORPM-2000A2020-04-16
B510PM2000APRO1ADVANCED PATIENT MONITORPM-2000A PRO2020-04-16
B510PM2000M1ADVANCED PATIENT MONITORPM-2000M2020-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04057027972793UFSK-OSYS Treatment tableUFSK-International OSYS GmbHFWY2026-03-02
00840763101169Ulthera System CartUlthera, Inc.FWY2024-05-21