FDA.reportPublic FDA data

G-SERIES SINGLE PORT BEAMSPLITTER, 95/5 VIRTUAL PORT, WHITE

Primary DI
00810040251863
Brand
G-SERIES SINGLE PORT BEAMSPLITTER, 95/5 VIRTUAL PORT, WHITE
Company
GLOBAL SURGICAL CORPORATION
Model
M W1061VA528
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
EPTMicroscope, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810040251863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040251863008100402518638100402518630810040251863

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
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
00890446104932OSSEOUS-Endoscrub 4 mm ( 0° )EON MEDITECH PRIVATE LIMITEDEPT2026-03-13
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
00840183528553BR Surgical, LLCBR Surgical, LLCEPT2024-11-05
00840183528546BR Surgical, LLCBR Surgical, LLCEPT2024-10-25
00840183528560BR Surgical, LLCBR Surgical, LLCEPT2024-10-24
00198506072710ELMED INCORPORATEDELMED INCORPORATEDEPT2024-10-23
00810040253836REP KIT FOR A-SERIES SCOPEGLOBAL SURGICAL CORPORATIONEPT2024-09-26
00810040254581LASER FILTER MODULEGLOBAL SURGICAL CORPORATIONEPT2024-09-26
00810040255113HD CAMERA, 1080P V2, A-SERIESGLOBAL SURGICAL CORPORATIONEPT2024-09-26
00810040255342CAMERA, 4K, USB POWERGLOBAL SURGICAL CORPORATIONEPT2024-09-26
00810040255397HD CAMERA, 1080P V2, FOR M725 SYS, INT'LGLOBAL SURGICAL CORPORATIONEPT2024-09-26