FDA.reportPublic FDA data

Hubble Digital Vision

Primary DI
00872320006471
Brand
Hubble Digital Vision
Company
CAO GROUP, INC.
Model
005-00109
Device description
Battery powered electronic magnification loupe and display system for use in clinical settings.
Published
2024-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
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
00872320006471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00872320006471008723200064718723200064710872320006471

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

Contacts#

Phone, Email table
PhoneEmail
877-877-9778customercare@caogroup.com

Regulatory Flags#

DUNS number
102422578
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
00872320005825LEAP Cavity Cleansing Solution006-002722026-04-10
00872320006440Picasso Pro Diode Laser002-004602026-04-10
00872320006617Picasso Pro Pre-initiated Laser Tip, Variety Pack002-004802026-04-10
00872320006846LEAP Laser Delivery Tip050832026-04-10
00872320006853Picasso Pro Pre-initiated Laser Tip, 300um, 5mm053792026-04-10
00872320006860Picasso Pro Pre-initiated Laser Tip, 300um, 10mm051932026-04-10
00872320006877Picasso Pro Pre-initiated Laser Tip, 400um, 5mm053802026-04-10
00872320006884Picasso Pro Pre-initiated Laser Tip, 400um, 10mm051942026-04-10
00872320006891Picasso Pro Disposable Therapy Tip, Straight052212026-04-10
00872320006907Picasso Pro Disposable Therapy Tip, Curved052222026-04-10
00872320006761Monet + Curing Laser001-001232026-02-10
00872320004477Ultimate Contour Mini005-000362019-09-06
00872320003364Pilot Diode Laser 600um Tip030932016-11-10
00872320003418Pilot Straight Tip006682016-11-10
00872320003425Pilot 60° Tip006692016-11-10
00872320003456Pilot Diode Laser030922016-11-10
00872320006457Acuity Direct X-Ray Photon Detection005-001232024-02-19
00872320006464Acuity Direct X-Ray Photon Detection005-002142024-02-19
00872320000127BlissBond Intro Kit006-00044006-000442016-11-10
00872320000141BlissEtch Intro Kit006-00029006-000292016-11-10

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