FDA.reportPublic FDA data

EXTARO® 300

Primary DI
06909262060354
Brand
EXTARO® 300
Company
Carl Zeiss Suzhou Co., Ltd.
Model
6035
Published
2022-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
06909262060354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06909262060354069092620603546909262060354

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
528182577
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
06909262200156Zeiss AxiovertAxiovert 5431030-9050-0002026-05-19
06909262061375OPMI® LUMERA® 30061372022-08-11
06909262060330EXTARO® 30060332022-08-11
06909262060347EXTARO® 30060342022-08-11
06909262100104EXTARO® 300000000-2327-7552022-08-11
06909262200040ZEISS Axio VertAxio Vert.A1431030-9000-0002021-01-01
06909262200057ZEISS Axio VertAxio Vert.A1431030-9010-0002021-01-01
06909262200064ZEISS Axio VertAxio Vert.A1431030-9040-0002021-01-01
06909262200118ZEISS Axio LabAxio Lab.A1430037-9010-0002021-01-01
06909262200125ZEISS Axio LabAxio Lab.A1430037-9020-0002021-01-01
06909262200231ZEISS AxiolabAxiolab 5430037-9011-0002021-01-01
06909262200248ZEISS AxiolabAxiolab 5430037-9021-0002021-01-01
06909262200286ZEISS AxiolabAxiolab 5430037-9060-0002021-01-01
06909262200293ZEISS AxiolabAxiolab 5430037-9070-0002021-01-01
06909262200316ZEISS Axio LabAxio Lab.A1430037-9000-0002021-01-01
06909262200323ZEISS AxioscopeAxioscope 5430035-9032-0002021-01-01
06909262200330ZEISS AxioscopeAxioscope 5430035-9061-0002021-01-01
06909262200378ZEISS AxioscopeAxioscope 5430035-9201-0002021-01-01
06909262200422ZEISS AxioscopeAxioscope 5430035-9261-0002021-01-01
06909262200460ZEISS AxiolabAxiolab 5430037-9110-0002021-01-01

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