FDA.reportPublic FDA data

ARveo 8x

Primary DI
07630802405906
Brand
ARveo 8x
Company
Leica Microsystems (Schweiz) AG
Model
10449213
Catalog number
10449213
Device description
ARveo 8x stand system for M530 microscope - for Leica surgical operating microscope system: ARveo 8x
Published
2025-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

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
07630802405906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630802405906076308024059067630802405906

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(984)7105152Iris.Pohl@leica-microsystems.com

Regulatory Flags#

DUNS number
480198725
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
07630003525472M844 Optics Carrier000000000010448197104481972020-09-22
07630802402622ARveo 8000000000010449157 104491572024-05-03
07630802403810MyVeo000000000010449167 104491672024-05-03
07630802403827MyVeo Headset000000000010449164 104491642024-05-02
07630003567717RUV800 WD175000000000010448555 104485552022-08-19
07630003567724Leica RUV800 WD200000000000010448556104485562022-08-19
07630003599008PROVEO 8 F42000000000010449058 104490582020-11-09
07630003598872ARveo 8000000000010449063 104490632021-10-08
07630003552188M220 F12000000000010448367104483672021-06-22
07630003580051Wireless Footswitch 14-functions000000000010448846104488462021-06-15
07630003581034Wireless Footswitch 12-functions000000000010448872 104488722021-06-15
07630003570908Leica Keratoscope000000000010448558 104485582020-09-25
07630003524475M620 Optics Carrier000000000010448294 104482942020-09-22
07630003525243M620 TTS000000000010448213 104482132020-09-22
07630003526233M844 F40 / M822 F40000000000010448142 104481422020-09-22
07630003526295M822 C40 / M822 CT40 / M844 C40 / M844 CT40000000000010448140 104481402020-09-22
07630003551907M525 F20000000000010448284104482842020-09-22
07630003551914M525 Optics Carrier000000000010448300 104483002020-09-22
07630003552195M620 F20000000000010448380104483802020-09-22
07630003568707M822 Optics Carrier000000000010448587104485872020-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551454121ARTip CRUISEKarl Storz GmbH & Co. KGEPT2026-11-02
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
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