FDA.reportPublic FDA data

AMTAI

Primary DI
00811889030183
Brand
AMTAI
Company
AMTAI MEDICAL EQUIPMENT, INC.
Model
ACC0014
Device description
Shoulder Supports, PU Foam (Right)
Published
2018-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FQOTable, Operating-Room, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811889030183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811889030183008118890301838118890301830811889030183

GMDN Terms#

Term, Definition table
TermDefinition
Universal operating table, electrohydraulicA mobile, mains electricity (AC-powered) hydraulic-mechanism table designed to be adjusted to support a patient during many types of surgical interventions. The table surface consists of many articulated sections that can be elevated or lowered for contouring to accommodate numerous anatomical positions (e.g., the whole table top may be adjusted to form a curved surface) to satisfy the requirements of many clinical specialties.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
830186198
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811889030749AMTAILS1-B-12018-07-06
00811889030756AMTAILS1-C-12018-07-06
00811889030763AMTAILS1-D-12018-07-06
00811889030770AMTAILS1-B-1(I)2018-07-06
00811889030787AMTAILS1-C-1(I)2018-07-06
00811889030794AMTAILS1-D-1(I)2018-07-06
00811889030800AMTAILS2-BB-12018-07-06
00811889030817AMTAILS2-BD-12018-07-06
00811889030824AMTAILS2-CB-12018-07-06
00811889030831AMTAILS2-CD-1 2018-07-06
00811889030848AMTAILS2-BB-1(I)2018-07-06
00811889030855AMTAILS2-BD-1(I)2018-07-06
00811889030862AMTAILS2-CB-1(I)2018-07-06
00811889030879AMTAILS2-CD-1(I) 2018-07-06
00811889030886AMTAILS3-BBA-1 2018-07-06
00811889030893AMTAILS3-BDA-12018-07-06
00811889030909AMTAILS3-CBA-1 2018-07-06
00811889030916AMTAILS3-CDA-1 2018-07-06
00811889030923AMTAILS3-BBA-1(I) 2018-07-06
00811889030930AMTAILS3-BDA-1(I) 2018-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995232016NASTERIS CORPORATIONFQO2026-05-26
00724995232023NASTERIS CORPORATIONFQO2026-05-26
00724995232054NASTERIS CORPORATIONFQO2026-05-26
00724995232061NASTERIS CORPORATIONFQO2026-05-26
00724995232078NASTERIS CORPORATIONFQO2026-05-26
04260217220899WB FA24Amtrion GmbHFQO2026-04-08
00724995362317HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362324HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362331HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362348HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362355HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362362HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362379HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362386HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362393HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362409HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362416HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362423HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362430HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362447HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362454HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
10841736124410Skytron 200 x 400 VESA Adapter PlateSKYTRON LLCFQO2026-03-19
04061591001032MultibarOndal Medical Systems GmbHFQO2026-02-02
00190376678665ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678672ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678689ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678740ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678757ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678764ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678771ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23