FDA.reportPublic FDA data

Vital Vue

Primary DI
10884521042520
Brand
Vital Vue
Company
Covidien LP
Model
8886828424
Device description
Sorgente di Luce
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBIILLUMINATOR, FIBEROPTIC, SURGICAL FIELD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBIIlluminator, Fiberoptic, Surgical FieldGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K883201000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K883201000VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYSVital Metrics, Inc.1988-09-26HBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521042520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452104252010884521042520

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose light sourceA mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature32 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521171534Nellcor10005941-SG2022-10-01
10884521163454Nellcor100059412016-09-24
10884521196728NellcorPM100N2016-09-24
10884521527607NellcorDLPM100N2017-08-03
10884521527591NellcorDSPM100N2017-05-29
40884522004061ShileyDDCP2015-09-01
10884521815353MicrostreamPMC40M-PH2023-06-12
10884521543799SigniaSIGPSHELL2017-08-08
10884521856271Touch SurgeryMDS300012026-10-16
10884521701243INVOSPMAC71DOC2024-04-14
10884521810105INVOSPM71002021-06-14
10884521780170INVOSPMAC71DOC2019-07-31
10884521780071INVOSPM71002019-06-12
10884521839830TrexonCY904P2026-10-10
10884521839861TrexonCY954P2026-10-10
10884521840089TrexonCY811P2026-10-10
10884521840126TrexonCY843P2026-10-10
10884521840140TrexonCY883P2026-10-10
10884521840171TrexonCY953P2026-10-10
10884521840195TrexonGY123P2026-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770419067Bausch + LombBausch & Lomb IncorporatedHBI2026-04-30
00857580006829Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2025-02-26
00857580006812Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2024-10-15
00816744027728NICO Myriad SPECTRANICO CORPORATIONHBI2024-06-07
00857580006805Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2024-06-07
00816835024216OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
00816835024223OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
00816835024230OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
00816835024247OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
01816835024215OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
01816835024222OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
01816835024239OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
01816835024246OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
00816744027704NICO Myriad NOVUSNICO CORPORATIONHBI2023-04-28
00857580006782Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2023-03-06
00857580006799Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2023-03-06
00851925007700Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.HBI2022-05-18
00851925007717Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.HBI2022-05-18
00851925007724Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.HBI2022-05-18
00851925007731Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.HBI2022-05-18
00851925007748Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.HBI2022-05-18
00851925007755Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.HBI2022-05-18
00851925007762Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.HBI2022-05-18
00851925007779Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.HBI2022-05-18
M678DPLS300W0Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM CustomerSUNOPTIC TECHNOLOGIES LLCHBI2022-02-25
00857580006775Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2021-10-20
00857580006768Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2021-03-18
00857580006751Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2021-02-18
00857580006713Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2019-03-04
00857580006706Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2018-09-20