FDA.reportPublic FDA data

Flexible Fiber Laryngoscope, Standard Set Recondit

Primary DI
00874485002955
Brand
Flexible Fiber Laryngoscope, Standard Set Recondit
Company
COGENTIX MEDICAL, INC.
Model
ENT-4000
Catalog number
02-4202P
Device description
Reconditioned
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EOBNasopharyngoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050972000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050972000VISION-SCIENCES ENT-3000 SCOPEVision-Sciences, Inc.2005-04-29EOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00874485002955PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00874485002955008744850029558744850029550874485002955

GMDN Terms#

Term, Definition table
TermDefinition
Flexible fibreoptic nasopharyngoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the nasopharynx (the upper part of the throat behind the nose). It is inserted through a nostril during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This is a reusable device.

Sterilization Methods#

Method table
Method
High-level Disinfectant

Contacts#

Phone, Email table
PhoneEmail
866-258-2182customercare@cogentixmedical.c

Regulatory Flags#

DUNS number
780024725
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00874485003180Endoscopic Cytology Brush07-90012016-09-23
00874485003197Nasal Cytology Brush07-90062016-09-23
00874485000844Flexible Video Esophagoscope (NTSC)TNE-500003-52012016-09-22
00874485002367Flexible Video Bronchoscope (NTSC)BRS-510004-52032016-09-22
00874485002848Flexible Video Bronchoscope (NTSC) ReconditionedBRS-510004-5203P2016-09-22
00874485002879Flexible Video Esophagoscope (NTSC) ReconditionedTNE-500003-5201P2016-09-22
00874485000318Portable LED Light SourceBLS-100007-30502016-09-23
00874485002985EndoSheath TechnologyTV-2.103-51012016-09-23
00874485003005EndoSheath TechnologyTV-1.503-51022016-09-23
00874485003029EndoSheath TechnologyBF-2.104-41012016-09-23
00874485003036EndoSheath TechnologyBF-1.504-41022016-09-23
00874485003043EndoSheath TechnologyBF-2.804-41032016-09-23
00874485003050EndoSheath TechnologyBF-004-41052016-09-23
00874485003067EndoSheath TechnologyBV-2.104-51012016-09-23
00874485003074EndoSheath TechnologyBV-1.504-51022016-09-23
00874485003098EndoSheath TechnologyBV-004-51052016-09-23
00874485003104EndoSheath TechnologyBVX-2.104-51112016-09-23
00874485003111EndoSheath TechnologyBVX-1.504-51122016-09-23
00874485003128EndoSheath TechnologyBVX-2.804-51132016-09-23
00874485003135EndoSheath TechnologyBVX-004-51152016-09-23

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