FDA.reportPublic FDA data

APEX 2510 EXAM CHAIR WITH MANUAL LIFT, MANUAL BACKREST RECLINE, ARTICULATING PIL

Primary DI
00810040253416
Brand
APEX 2510 EXAM CHAIR WITH MANUAL LIFT, MANUAL BACKREST RECLINE, ARTICULATING PIL
Company
GLOBAL SURGICAL CORPORATION
Model
S 251000
Published
2021-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00810040253416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040253416008100402534168100402534160810040253416

GMDN Terms#

Term, Definition table
TermDefinition
ENT chair, mechanicalA manually- or hydraulically-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
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

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
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
00810040253843STANDARD STOOL, ROUND SEAT WITH NO BACKREST, AUTO-LIFT, 5-LEGS 1345002021-09-21
00810040253850B-STOOL, SQUARE SEAT WITH BACKREST, AUTO-LIFT, 5-LEGS 1365002021-09-21
00810040253867C-STOOL, ROUND SEAT WITH BACKREST, AUTO-LIFT, 5-LEGS 1385002021-09-21
00810040253904CUSTOMIZED SMR EXAM CHAIRS CUSTOM2021-09-21
00810040253935CUSTOMIZED SMR CABINET, OR CABINET COMPONENTS CUSTOM2021-09-21
00810040253942CUSTOMIZED SMR STOOLS CUSTOM2021-09-21
00810040253973ASSY, 110V PRESSURE PUMP, DULONG102-032-6202021-09-21
00810040253980ASSY, 110V VACUUM PUMP, DULONG102-032-6212021-09-21
00810040253997ASSY, 110V PRESSURE PUMP102-032-6222021-09-21

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
00728564010005Versa Exam TableThe Brewer Company LLCFRK2025-11-10
00728564015000Blood Drawing ChairThe Brewer Company LLCFRK2025-11-10
00728564020103Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564020301Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564020400Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564021100Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564021308Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564021407Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564022107Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564022305Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564022404Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564050001Access Exam TableThe Brewer Company LLCFRK2025-11-10
00728564050018Access Exam TableThe Brewer Company LLCFRK2025-11-10
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
D974BSI29111BritedentBright Supply, Inc.FRK2025-03-11
D974BSI29112BritedentBright Supply, Inc.FRK2025-03-11
00198506075179ELMED INCORPORATEDELMED INCORPORATEDFRK2025-02-17
00842180190122ELMEDELMED INCORPORATEDFRK2024-04-09
00842180147768ELMEDELMED INCORPORATEDFRK2024-03-06