FDA.reportPublic FDA data

InstaClear

Primary DI
00821925041493
Brand
InstaClear
Company
Gyrus ACMI, LLC
Model
LCS4K45TPOL
Device description
SHEATH, LENS CLEANER ULTRA 45 DEGREES, TOP LIGHT InstaClear (5/PK)
Published
2024-04-22
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

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
K152531000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152531000InstaClear Lens CleanerGyrus Acmi, Inc.2016-01-15EOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925041424PackageGS15In Commercial Distribution
00821925041493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925041424008219250414248219250414240821925041424
00821925041493008219250414938219250414930821925041493

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.

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925034433Gyrus ACMI1315002016-10-07
00821925002104USA Elite SystemEOS-HCF272024-11-21
00821925002074USA Elite SystemEOS-CFR-252024-07-25
00821925002470SlimlineGYA-52024-07-24
00821925002494SlimLineGYB-52024-07-24
00821925002562SlimLineGYS-52024-07-24
00821925002579GYRUS ACMI, INCGYS-7422024-07-24
00821925004634Gyrus ACMI2442024-07-23
00821925001152URO-GUIDE54960162015-10-24
00821925001169URO-GUIDE54960202015-10-24
00821925001480USA EliteCLO-232016-10-13
00821925001497USA EliteCLS-232016-10-13
00821925001602Elite 2 SystemE2RIS-CF272016-10-13
00821925001626Elite 2 SystemE2ROS-CF272016-10-13
00821925001633Elite 2 SystemE2RST-CF252016-10-13
00821925001657Elite 2 SystemE2RTO-CF252016-10-13
00821925001664Elite 2 SystemE2RTO-CF272016-10-13
00821925001671Elite 2 SystemE2RVO-CF252016-10-13
00821925001688Elite 2 SystemE2RVO-CF272016-10-13
00821925001695Elite 2 SystemE2TO-CF252016-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327631395N/ASTRYKER CORPORATIONEOB2026-06-19
07613327631388N/ASTRYKER CORPORATIONEOB2026-06-16
07613327632774N/ASTRYKER CORPORATIONEOB2026-06-16
00840319759011Hayden MedicalHayden Medical, Inc.EOB2026-05-01
04719872715016MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOB2026-04-29
04719872715023MiiS Horus Video BoxMEDIMAGING INTEGRATED SOLUTION INC.EOB2026-04-29
04961333255238VIVIDEOHOYA CORPORATIONEOB2025-12-19
04961333255306VIVIDEOHOYA CORPORATIONEOB2025-12-19
00858119004194Entity XL Plus NasopharyngoscopeOPTIM LLCEOB2024-06-19
00858119004200Entity SDXL Plus NasopharyngoscopeOPTIM LLCEOB2024-06-19
00858119004217Entity XL USB NasopharyngoscopeOPTIM LLCEOB2024-06-19
00821925041462InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041479InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041486InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041509InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041516InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041523InstaClearGyrus ACMI, LLCEOB2024-04-22
04961333239825VIVIDEOHOYA CORPORATIONEOB2024-02-07
07290016539226Colibri micro-ENT Scope3NT MEDICAL LTDEOB2023-12-31
04961333070367PENTAXHOYA CORPORATIONEOB2023-07-31
04961333075164PENTAXHOYA CORPORATIONEOB2023-07-31
04961333077984PENTAXHOYA CORPORATIONEOB2023-07-31
04961333084562PENTAXHOYA CORPORATIONEOB2023-07-31
04961333134052PENTAXHOYA CORPORATIONEOB2023-07-31
04961333134359PENTAXHOYA CORPORATIONEOB2023-07-31
04961333171262PENTAXHOYA CORPORATIONEOB2023-07-31
04961333221073PENTAX MedicalHOYA CORPORATIONEOB2023-07-31
04961333221448PENTAX MedicalHOYA CORPORATIONEOB2023-07-31
04961333221455PENTAX MedicalHOYA CORPORATIONEOB2023-07-31
04961333226153PENTAXHOYA CORPORATIONEOB2023-07-31