FDA.reportPublic FDA data

BETACLASSIC

Primary DI
06970283131088
Brand
BETACLASSIC
Company
Maquet (Suzhou) Co. LTD
Model
1118.01K0
Device description
Mobile Operating Table
Published
2022-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSETable, Operating-Room, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSETable, Operating-Room, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970283131088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970283131088069702831310886970283131088

GMDN Terms#

Term, Definition table
TermDefinition
Universal operating table, hydraulicA mobile, manually-operated hydraulic 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. It is typically operated via an integral foot-pedal(s) that adjust the table top position.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
545372336
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
06970283130944Pair of leg plates1118.60F0111860F02022-12-07
06970283131156ALPHACLASSIC PRO1118.06F02022-11-29
06970283131163ALPHACLASSIC PRO1118.06F12022-11-29
06970283130814Infusion Transfer SystemM-SHIFT 2022-12-07
06970283130982MODUEVOMODUEVO-MA2022-12-07
06970283130999MODUEVOPLG-II2022-12-07
06970283131002MODUEVOENERGY2022-12-07
06970283131019MODUEVOCARGOLIFT2022-12-07
06970283131026MODUEVOMODUEVO BRIDGE2022-12-07
06970283131057Maquet Lyra1118.10F02022-12-07
06970283131064Maquet Lyra1118.10F12022-12-07
06970283131071BETACLASSIC1118.01B01118.01B02022-12-07
06970283131095Swivel Arm BoardSU01049900032022-12-07
06970283131101Swivel Arm BoardSU01049900042022-12-07
06970283131118Body Strap1001.59G02022-12-07
06970283131125Body Strap1001.59F02022-12-07
06970283131149Infusion Transfer SystemM-SHIFT Trolley2022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810057372100SchureMedSCHUERCH CORPORATIONFSE2025-10-29
00194613018436MSI Precision Specialty InstrumentsMed Saver, Inc.FSE2025-08-01
00194613121105MSI Precision Specialty InstrumentsMed Saver, Inc.FSE2025-08-01
06970283131071BETACLASSICMaquet (Suzhou) Co. LTDFSE2022-12-07
04046768039599BETACLASSIC mobile operating tableMAQUET GmbHFSE2022-09-22
ESOT002021NAS & T AGFSE2022-09-15
ESOT006091NAS & T AGFSE2022-09-15
00810057373794SchureMedSCHUERCH CORPORATIONFSE2021-09-10
00810057373787SchureMedSCHUERCH CORPORATIONFSE2021-09-02
00860006920708Morzine Medical Morzine Medical LLCFSE2021-07-21
00810057371431SchureMedSCHUERCH CORPORATIONFSE2020-09-08
00810057371448SchureMedSCHUERCH CORPORATIONFSE2020-09-08
00810045921716ISIINSTRUMENT SPECIALISTS, INC.FSE2020-07-30
00810045921723ISIINSTRUMENT SPECIALISTS, INC.FSE2020-07-30
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00810045920092C-ThruINSTRUMENT SPECIALISTS, INC.FSE2020-07-23
00810045920108C-ThruINSTRUMENT SPECIALISTS, INC.FSE2020-07-23
00810045920115C-ThruINSTRUMENT SPECIALISTS, INC.FSE2020-07-23
00810045920122C-ThruINSTRUMENT SPECIALISTS, INC.FSE2020-07-23
00810045920139C-ThruINSTRUMENT SPECIALISTS, INC.FSE2020-07-23