FDA.reportPublic FDA data

SchureMed

Primary DI
00810057372100
Brand
SchureMed
Company
SCHUERCH CORPORATION
Model
800-0370
Catalog number
3-041-01
Device description
Skytron Beach Chair
Published
2025-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00810057372100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810057372100008100573721008100573721000810057372100

GMDN Terms#

Term, Definition table
TermDefinition
General examination/treatment chair, manualA manually-operated device designed to support and position the patient in a seated or reclined posture for easy access and patient comfort during a diagnostic examination, medical treatment, and/or surgical procedure across specialties. It usually has moveable components and may include special features such as a raising and lowering mechanism and removable arms. For chairs involving the use of medical systems that emit and/or detect energy (e.g., ionizing or non-ionizing radiation, ultrasound, heat, light) see the respective chair terms for those systems.

Contacts#

Phone, Email table
PhoneEmail
1-781-982-7000a.panchal@schuremed.com

Regulatory Flags#

DUNS number
964322929
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810014600178SchureMed539-0019 and 539-0018800-01642019-03-12
00810014602967SchureMed800-0164800-01642021-05-10
00810014602981SchureMed800-0164-ST2021-06-07
00810014602998SchureMed800-0164-T2021-06-07
00810014603001SchureMed800-0164-T-INT2021-06-07
00810057374302SchureMed800-0369-SKY3-040-222025-10-29
00810014602974SchureMed800-0164-SKY3-040-33-12019-06-13
00810014602585SchureMed800-0039-B2021-03-31
00810014602943SchureMed800-00392021-03-31
00810014603841SchureMed800-03692021-03-31
10841736116910SchureMed800-0039-SKY2021-03-31
00810014600154SchureMed800-0039800-00392019-02-21
00810014600642SchureMed800-0039-SKY800-0039-SKY2019-06-13
00810014601267SchureMed800-0039-M800-0039-M2019-06-13
00810014600277SchureMed508-1345508-13452019-06-11
00810014600444SchureMed800-0039-ST800-0039-ST2019-06-11
00810014600598SchureMed800-00153-040-242025-10-29
00810014600666SchureMed800-00893-040-20-182025-10-29
00810014600833SchureMed800-03113-040-122025-10-29
00810014602714SchureMed800-0091-SKY3-040-20-162025-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613018436MSI Precision Specialty InstrumentsMed Saver, Inc.FSE2025-08-01
00194613121105MSI Precision Specialty InstrumentsMed Saver, Inc.FSE2025-08-01
06970283131071BETACLASSICMaquet (Suzhou) Co. LTDFSE2022-12-07
06970283131088BETACLASSICMaquet (Suzhou) Co. LTDFSE2022-11-29
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
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00810045921846ISIINSTRUMENT SPECIALISTS, INC.FSE2020-07-30
00810045921853ISIINSTRUMENT SPECIALISTS, INC.FSE2020-07-30
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