FDA.reportPublic FDA data

GALAXY JUPITER S3.F4 [SZER. 64 CM]

Primary DI
05903684800674
Brand
GALAXY JUPITER S3.F4 [SZER. 64 CM]
Company
MEDEN INMED SP Z O O
Model
01-STO-1207-001
Catalog number
3133
Device description
The Galaxy massage table is a treatment table designed to facilitate manual therapies and massage treatments.
Published
2022-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
INQTable, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INQTable, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05903684800674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05903684800674059036848006745903684800674

GMDN Terms#

Term, Definition table
TermDefinition
Examination/treatment table, line-poweredA mobile, mains electricity (AC-powered) motorized table designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework or a large pedestal with a flat table top surface which consists of some articulated sections that can be adjusted into a raised position. The height of the table top surface will also be power-adjusted. It is typically used in examination rooms, endoscopy facilities, electrophysiology (EP) laboratories, or outpatient departments for minor interventions.

Regulatory Flags#

DUNS number
367142903
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05903684801756MONTANE ATLAS M-P3.F0 [SZER 69 CM]01-STO-3020-00135372022-11-04
05903684801817MONTANE ATLAS M-P3.F4 [SZER 69 CM]01-STO-3021-00135382022-11-04
05903684802074MONTANE ALPS M-P5.F4 [SZER 69 CM]01-STO-3023-00135582022-11-04
05903684800957GALAXY MERCURY S4.F4-H [SZER. 64 CM]01-STO-1265-00131412022-11-03
05903684801350MONTANE TATRAS M-S2.F0 [SZER 69 CM]01-STO-3002-00135222022-11-03
05903684801640MONTANE ATLAS M-S3.F0 [SZER. 69 CM] US01-STO-3006-00435302022-11-03
05903684801671MONTANE ATLAS M-S3.F4 [SZER 69 CM]01-STO-3007-00135362022-11-04
05903684801428MONTANE TATRAS M-S2.F0 [SZER 69 CM]01-STO-3002-00435202022-11-03
05903684801459MONTANE TATRAS M-S2.F4 [SZER 69 CM]01-STO-3003-00135232022-11-03
05903684801619MONTANE ATLAS M-S3.F0 [SZER. 69 CM]01-STO-3006-00135352022-11-03
05903684801251GALAXY TRACTION T3.F0 [SZER 70 CM] XL01-STO-3407-00532632023-11-15
05903684801299GALAXY TRACTION T3.F4 XL [SZER 70 CM]01-STO-3408-00532642023-11-15
05903684801381GALAXY TRACTION T4.F4 XL [SZER 70 CM] 01-STO-3424-00532672023-11-15
05903684803248TRITON 6 E (SZER. 69) 01-STO-3620-0024769E2023-11-06
05903684802319MONTANE ANDES M-P7.F4 [SZER 76 CM]01-STO-3025-0053573XL2023-09-25
05903684802142TRITON 6 E (SZER. 70) 01-STO-3620-0014769E2022-11-07
05903684803231TRITON 6 M (SZER. 70) 01-STO-3610-0024769M2022-11-07
05903684800315MONTANE TATRAS GERLACH E-S2.F4 [SZER. 69 CM]01-STO-3031-00135252022-11-04
05903684801787MONTANE ATLAS M-P3.F0 [SZER 69 CM] US01-STO-3020-00435322022-11-04
05903684801848MONTANE ATLAS M-P3.F4 [SZER 69 CM] US01-STO-3021-00435332022-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00810045933313Clinton IndustriesCLINTON INDUSTRIES, INC.INQ2026-07-29
00810045933320Clinton IndustriesCLINTON INDUSTRIES, INC.INQ2026-07-29
00810045933337Clinton IndustriesCLINTON INDUSTRIES, INC.INQ2026-07-29
06975582543938COINFYCAREHuangshan Jinfu Medical Equipment Co.,Ltd.INQ2026-07-06
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