FDA.reportPublic FDA data

Vital Vue

Primary DI
20884521176116
Brand
Vital Vue
Company
Covidien LP
Model
8886828306
Catalog number
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
OTC
false
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521072602V-LocVLOCN204L2015-09-02
20884521126852Sofsilk1700022016-09-24
10884521091986NellcorSC-A-I2026-05-25
10884521758803Vascufil8886470311V-22020-07-19
10884521816312McGRATH MAC350-005-0002021-10-21
10884521816329McGRATH MAC350-013-0002021-08-30
10884521816336McGRATH MAC350-017-0002021-10-18
10884521816343McGRATH MAC350-072-0002022-06-13
10884521824317McGRATH MAC350-005-0002022-09-25
10884521824324McGRATH MAC350-013-0002021-10-30
10884521824331McGRATH MAC350-017-0002021-08-26
10884521824348McGRATH MAC350-072-0002023-06-19
10884521850118McGRATH MAC350-005-0002025-04-27
10884521850125McGRATH MAC350-013-0002025-04-27
10884521850132McGRATH MAC350-017-0002025-04-27
10884521850149McGRATH MAC350-072-0002025-04-27
15060272980310McGRATH MAC350-005-0002021-08-02
15060272980327McGRATH MAC350-013-0002022-01-17
15060272980334McGRATH MAC350-072-0002021-04-18
15060272980341McGRATH MAC350-017-0002021-03-27

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Primary DI, Brand, Company table
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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