FDA.reportPublic FDA data

Vital Vue

Primary DI
10884521176119
Brand
Vital Vue
Company
Covidien LP
Model
8886828306
Device description
Orthopedic Tip Instrument
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
20884521176116PackageGS16In Commercial Distribution
10884521176119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452117611620884521176116
1088452117611910884521176119

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, illuminating, single-useAn atraumatic, invasive, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or clear an airway obstruction, whilst providing illumination of the site. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic, nor an intravascular device; it is not designed for surgical irrigation. It has a built-in light or fibreoptic bundle used to illuminate the operative site. Often referred to a as suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or tubing. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521845985INVOSPMC71VP-GE2025-07-03
10884521063150ILA3948L2015-08-28
10884521102422Steel88862345-532015-08-31
10884521103863TaperGuard18780S2016-09-24
10884521211933Shiley5-182372017-05-10
10884521543799SigniaSIGPSHELL2017-08-08
10884521713208EdgeE1455B2016-11-18
10884521713277EdgeE1475X2016-11-18
20884521103631Mallinckrodt5-182372015-08-28
20884521105574Mallinckrodt5-185412015-08-28
40884521105578Shiley5-185412018-05-16
10884521543881SigniaSIGMRET2017-07-24
10884521543874SigniaSIGRIG2017-07-31
10884521620254Shiley862342016-09-24
10884521543812SigniaSIGADAPTXL2017-08-08
10884521101098NellcorMAXPACAI2016-09-24
10884521543782SigniaSIGPHANDLE2017-08-08
10884521543867SigniaSIGSBCHGR2017-08-01
10884521128927SonicisionSCST2016-09-24
10884521543829SigniaSIGADAPTSHORT2017-09-12

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