FDA.reportPublic FDA data

Gemini Plus

Primary DI
00851321006116
Brand
Gemini Plus
Company
VITALCOR, INC
Model
847211
Catalog number
847211
Device description
Gemini Plus Surgical Headlight
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCTHeadlight, fiberoptic focusing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCTHeadlight, Fiberoptic FocusingOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851321006116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851321006116008513210061168513210061160851321006116

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic operating light systemA system of lights intended to be used in the operating room (OR) to illuminate the surgical site over a prolonged period for optimal visualization of small, low-contrast objects at varying depths or through small incisions. It operates through light provided by a light source, usually located outside of the surgical field, which is delivered through fibreoptic cables to the site of operation. The cables will be mounted, e.g., from the ceiling or attached to a suitable floor mount, or they may possibly connect directly to the surgeons head-worn head light.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)874-8358info@vitalcor.com

Regulatory Flags#

DUNS number
020942546
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851321006000Coronary Artery Perfusion Cannula3158043158042016-09-16
00851321006017Coronary Artery Perfusion Cannula3158053158052016-09-16
00851321006024Coronary Artery Perfusion Cannula3158063158062016-09-16
00851321006031Coronary Artery Perfusion Cannula3158073158072016-09-16
00851321006048Coronary Artery Perfusion Cannula3158083158082016-09-16
00851321006055Coronary Artery Perfusion Cannula4158044158042016-09-16
00851321006062Coronary Artery Perfusion Cannula4158064158062016-09-16
00851321006079Coronary Artery Perfusion Cannula4158054158052016-09-16
00851321006086Coronary Artery Perfusion Cannula4158074158072016-09-16
00851321006093Coronary Artery Perfusion Cannula4158084158082016-09-16
10851321006007Coronary Artery Perfusion Cannula3158043158042016-09-16
10851321006014Coronary Artery Perfusion Cannula3158053158052016-09-16
10851321006021Coronary Artery Perfusion Cannula3158063158062016-09-16
10851321006038Coronary Artery Perfusion Cannula3158073158072016-09-16
10851321006045Coronary Artery Perfusion Cannula3158083158082016-09-16
10851321006052Coronary Artery Perfusion Cannula4158044158042016-09-16
10851321006069Coronary Artery Perfusion Cannula4158064158062016-09-16
10851321006076Coronary Artery Perfusion Cannula4158054158052016-09-16
10851321006083Coronary Artery Perfusion Cannula4158074158072016-09-16
10851321006090Coronary Artery Perfusion Cannula4158084158082016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013851521Altair HI 2QED, INC.FCT2025-05-21
00860013851538Altair SAQED, INC.FCT2025-05-21
00840183529192BR Surgical, LLCBR Surgical, LLCFCT2024-12-02
00840183500559BR Surgical, LLCBR Surgical, LLCFCT2024-07-22
00840183501136BR Surgical, LLCBR Surgical, LLCFCT2024-07-22
00840183512989BR Surgical, LLCBR Surgical, LLCFCT2024-07-22
00816835023967IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
00816835023974IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
00816835023981IsoLED II LED HLMedical Illumination International Inc.FCT2023-10-02
00816835023998IsoLED II LED HLMedical Illumination International Inc.FCT2023-10-02
00816835024018IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
00816835024025IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
00816835024032IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
00816835024056Magnum LED HLMedical Illumination International Inc.FCT2023-10-02
00816835024063Magnum LED HLMedical Illumination International Inc.FCT2023-10-02
00816835023950IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
01816835023966IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
01816835023973IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
01816835023980IsoLED II LED HLMedical Illumination International Inc.FCT2023-10-02
01816835023997IsoLED II LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024017IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024024IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024031IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024055Magnum LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024062Magnum LED HLMedical Illumination International Inc.FCT2023-10-02
B366HDL200FIBEROPTIC HEADLUXEclerisFCT2022-06-10
00862658000326Fiberoptics Technology IncFIBEROPTICS TECHNOLOGY, INC.FCT2021-07-26
04055207008751NARichard Wolf GmbHFCT2018-10-17
M678HL0Sunoptic TechnologiesSUNOPTIC TECHNOLOGIES LLCFCT2017-05-09
M678HLM0Sunoptic TechnologiesSUNOPTIC TECHNOLOGIES LLCFCT2017-05-09