FDA.reportPublic FDA data

MAXI 4500 EXAM CHAIR/TABLE, WITH MOTORIZED LIFT/TILT/RECLINE TO FLAT, TRENDELENB

Primary DI
00810040253331
Brand
MAXI 4500 EXAM CHAIR/TABLE, WITH MOTORIZED LIFT/TILT/RECLINE TO FLAT, TRENDELENB
Company
GLOBAL SURGICAL CORPORATION
Model
S 4570000CT
Published
2021-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FRKChair, Examination And Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRKChair, Examination And TreatmentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810040253331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040253331008100402533318100402533310810040253331

GMDN Terms#

Term, Definition table
TermDefinition
ENT chair, electricA mains electricity (AC-powered) device designed to support a patient in a seated position to facilitate ear, nose, throat (i.e., ENT) examination, treatment, and/or minor surgery. It is typically adjustable in height to enable healthcare staff to perform procedures while standing. It usually includes head and armrests, a reclining back that may be tilted from a vertical to a horizontal position, and has rotating capabilities; some types can be programmed to standard positions. Devices intended for ENT examination and/or treatment (e.g., otoscopes, laryngoscopes) may be attached as components of the chair, or stand separately as self-supported, wall- or ceiling-mounted units.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
824793335
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00810040253836REP KIT FOR A-SERIES SCOPEM A730RK2024-09-26
00810040254581LASER FILTER MODULEM 1047LFM2024-09-26
00810040255113HD CAMERA, 1080P V2, A-SERIESM A517HD1080V22024-09-26
00810040255342CAMERA, 4K, USB POWERM 517-4K2024-09-26
00810040255397HD CAMERA, 1080P V2, FOR M725 SYS, INT'LM 517HD1080V2-725I2024-09-26
00810040255403LED LIGHT SOURCE, A-SERIES, V2M A801-LEDV22024-09-26
00810040255434A-SERIES SUPPORT ARM, HORIZONTAL, V2M A730-HAV22024-09-26
00810040255441A-SERIES SUPPORT ARM, 45 DEGREE, V2M A730-45AV22024-09-26
00810040250989CAMERA COUPLER, T-MOUNT TO CANON "EF" MOUNTM 528XSLR-EOS2022-09-20
00810040250996CAMERA COUPLER, T-MOUNT TO NIKON "F" MOUNTM 528XSLR-F2022-09-20
00810040251009CAMERA COUPLER, T-MOUNT TO SONY "E" MOUNTM 528XSLR-NEX2022-09-20
00810040251016FLAT PANEL MONITOR, SELECT SIZE: 22"-31", SELECT COLOR: BLACK OR WHITEM 547FS222022-09-20
00810040251023WALLMOUNT FOR FLAT PANEL MONITOR, </= 45 poundsM 547FSWMB2022-09-20
00810040253706WALL MOUNT BOARD FOR 32" METAL STUDS, WHITEM W557-322021-09-21
00810040253713WALL MOUNT BOARD FOR 24" STUDS, WHITEM W5572021-09-21
00810040253720LED LIGHT SOURCE WITH TURRET: ACMI, WOLF, OLYMPUS, KARL STORZ, TABLE TOP VERSIONS 740200LEDTT2021-09-21
00810040253737LED LIGHT SOURCE WITH TURRET: ACMI, WOLF, OLYMPUS, KARL STORZ, TABLE TOP VERSIONS 740200LEDTT-2302021-09-21
00810040253744LED LIGHT SOURCE WITH TURRET: ACMI, WOLF, OLYMPUS, KARL STORZ, 230VS 740200LED2302021-09-21
00810040253751OBJECTIVE LENS, F=250MM, FIXEDM 10302021-09-21
00810040253768OBJECTIVE LENS, F=200MM, FIXEDM 10312021-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08500190351415Maxi S4000 Exam Chair, Power Base/Recline, Arms, Art HR, WhiteBoyd Industries, Inc.FRK2025-12-26
00840456201015JMUJMU DENTAL, INCFRK2025-07-15
00840456201022JMUJMU DENTAL, INCFRK2025-07-15
00840456201039JMUJMU DENTAL, INCFRK2025-07-15
00840456201046JMUJMU DENTAL, INCFRK2025-07-15
00840456202906JMUJMU DENTAL, INCFRK2025-07-15
00840456202913JMUJMU DENTAL, INCFRK2025-07-15
00840456202920JMUJMU DENTAL, INCFRK2025-07-15
00840456202937JMUJMU DENTAL, INCFRK2025-07-15
00198506083952ELMED INCORPORATEDELMED INCORPORATEDFRK2025-07-11
06973134772133silverfoxSilverfox Corporation LimitedFRK2025-07-09
06973134774113silverfoxSilverfox Corporation LimitedFRK2025-07-09
D974BSI29112BritedentBright Supply, Inc.FRK2025-03-11
00198506075179ELMED INCORPORATEDELMED INCORPORATEDFRK2025-02-17
00842180190122ELMEDELMED INCORPORATEDFRK2024-04-09
00842180147768ELMEDELMED INCORPORATEDFRK2024-03-06
06973134774052silverfoxSilverfox Corporation LimitedFRK2023-12-15
06973134774069silverfoxSilverfox Corporation LimitedFRK2023-12-15
06973134774076silverfoxSilverfox Corporation LimitedFRK2023-12-15
06973134774083silverfoxSilverfox Corporation LimitedFRK2023-12-15
06973134774090silverfoxSilverfox Corporation LimitedFRK2023-12-15
06973134774014silverfoxSilverfox Corporation LimitedFRK2023-12-14
06973134774021silverfoxSilverfox Corporation LimitedFRK2023-12-14
06973134774038silverfoxSilverfox Corporation LimitedFRK2023-12-14
06973134774045silverfoxSilverfox Corporation LimitedFRK2023-12-14
07285640010005Versa Exam TableThe Brewer Company LLCFRK2023-10-10
07285640015000Blood Drawing ChairThe Brewer Company LLCFRK2023-10-10
07285640020103Element Treatment TableThe Brewer Company LLCFRK2023-10-10
07285640020301Element Treatment TableThe Brewer Company LLCFRK2023-10-10
07285640020400Element Treatment TableThe Brewer Company LLCFRK2023-10-10