FDA.reportPublic FDA data

"EXTEN ARM 8"" BGE ENTREE PROTEGE"

Primary DI
00810040251429
Brand
"EXTEN ARM 8"" BGE ENTREE PROTEGE"
Company
GLOBAL SURGICAL CORPORATION
Model
M 713E
Published
2021-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EPTMicroscope, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPTMicroscope, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810040251429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040251429008100402514298100402514290810040251429

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical microscopeA general-purpose, surgical, light (optical) magnification instrument, usually stereoscopic, designed to magnify minute structures, e.g., nerves or vessels in the performance of delicate surgical procedures which require high magnification by transmitted light. An operating microscope will often be equipped with motorized focusing, adjustable magnification mechanisms (manual, zoom or both), backup lamps, and inclined tubes that permit the surgeon to see the field from a vertical perspective while keeping the head erect. Dual or multiple observation capability and the optical integration of still, motion picture and video cameras are common features. It can be fixed or mobile.

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
00890446104932OSSEOUS-Endoscrub 4 mm ( 0° )EON MEDITECH PRIVATE LIMITEDEPT2026-03-13
00860014850509HMDmd Wearable Surgical MonitorHMDMD INC.EPT2025-11-22
07630003501421M320 Optics CarrierLeica Microsystems (Schweiz) AGEPT2025-10-22
07630003501629M320 Optics CarrierLeica Microsystems (Schweiz) AGEPT2025-10-22
07630003501636M320 Optics CarrierLeica Microsystems (Schweiz) AGEPT2025-10-22
07630003501643M320 Optics CarrierLeica Microsystems (Schweiz) AGEPT2025-10-22
07630802405906ARveo 8xLeica Microsystems (Schweiz) AGEPT2025-09-17
04547497753058Mielscope +YOSHIDA DENTAL MFG. CO., LTD., THEEPT2025-09-01
B366U1OM200CLR02MICROSCOPEEclerisEPT2025-06-30
B366U1OM200CR02MICROSCOPEEclerisEPT2025-06-30
B366U1OM200FLR02MICROSCOPEEclerisEPT2025-06-30
B366U1OM200FR02MICROSCOPEEclerisEPT2025-06-30
B366U1OM200TLR02MICROSCOPEEclerisEPT2025-06-30
B366U1OM200TR02MICROSCOPEEclerisEPT2025-06-30
B366U1OM200WLR02MICROSCOPEEclerisEPT2025-06-30
B366U1OM200WR02MICROSCOPEEclerisEPT2025-06-30
06941877821456EighteethChangzhou Sifary Medical Technology Co., Ltd.EPT2025-04-17
04048551432099NAKarl Storz GmbH & Co. KGEPT2025-03-28
04048551432105NAKarl Storz GmbH & Co. KGEPT2025-03-28
04048551432174NAKarl Storz GmbH & Co. KGEPT2025-03-28
04048551432518NAKarl Storz GmbH & Co. KGEPT2025-03-28
04048551469262NAKarl Storz GmbH & Co. KGEPT2025-03-28
06977585090051EXTARO 300Carl Zeiss Meditec (Suzhou) Co., Ltd.EPT2025-03-26
06977585090099EXTARO 300Carl Zeiss Meditec (Suzhou) Co., Ltd.EPT2025-03-26
06977585090129EXTARO 300Carl Zeiss Meditec (Suzhou) Co., Ltd.EPT2025-03-26
06977585090136EXTARO 300Carl Zeiss Meditec (Suzhou) Co., Ltd.EPT2025-03-26
00840183528461BR Surgical, LLCBR Surgical, LLCEPT2024-11-07
00840183528553BR Surgical, LLCBR Surgical, LLCEPT2024-11-05
00840183528546BR Surgical, LLCBR Surgical, LLCEPT2024-10-25
00840183528560BR Surgical, LLCBR Surgical, LLCEPT2024-10-24