FDA.reportPublic FDA data

Olympus

Primary DI
00821925033924
Brand
Olympus
Company
Gyrus ACMI, LLC
Model
70140095
Device description
EARWICK, 16 mm x 2 mm x 2 mm (polyvinyl alcohol sponge) (4/Pk)
Published
2018-09-12
Public version status
Update
Distribution status
Not 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
KCNEAR WICK

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCNEar WickEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925030763PackageGS14Not in Commercial Distribution
00821925033924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925030763008219250307638219250307630821925030763
00821925033924008219250339248219250339240821925033924

GMDN Terms#

Term, Definition table
TermDefinition
Ear wick, non-biodegradableA non-biodegradable packing material [e.g., loosely twisted unspun cotton, gauze, or polyvinyl alcohol (PVA)] intended to be used in the ear of a patient after internal ear surgery, and/or to administer medicinal substances to the ear to treat ear disorders. This is a single-use device.

Regulatory Flags#

DUNS number
007198742
Device count
1
Premarket exempt
true
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
00763000888916MerocelMEDTRONIC XOMED, INC.KCN2026-02-15
00763000888923MerocelMEDTRONIC XOMED, INC.KCN2026-02-15
20763000888910MerocelMEDTRONIC XOMED, INC.KCN2026-02-15
20763000888927MerocelMEDTRONIC XOMED, INC.KCN2026-02-15
08904428722648OSSEOUS PVA Eye SpearsEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722655OSSEOUS PVA PointsEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722662OSSEOUS PVA Corneal Light Shield EON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722679OSSEOUS PVA Corneal Light ShieldEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722686OSSEOUS PVA Corneal Light ShieldEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722693OSSEOUS PVA lASIK Eye DrainEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722709OSSEOUS PVA LASIK Eye DrainEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722716OSSEOUS PVA Eye Drain EON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722723OSSEOUS PVA Eye Drain LargeEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722730OSSEOUS PVA Eye WickEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722747OSSEOUS PVA Eye Wick and WipeEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722754OSSEOUS PVA LASIK EYE EON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722761OSSEOUS OSSEOUS PVA LASIK EYE Shield EON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722778OSSEOUS PVA LASIK EYEEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722785OSSEOUS PVA Instrument WipeEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722792OSSEOUS PVA Wick and WipeEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428746576OSSEOUS PVA Eye SpearsEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428746583OSSEOUS PVA PointsEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428746590OSSEOUS PVA Corneal Light Shield EON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428746606OSSEOUS PVA Corneal Light ShieldEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428746613OSSEOUS PVA Corneal Light ShieldEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428746620OSSEOUS PVA lASIK Eye DrainEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428746637OSSEOUS PVA LASIK Eye DrainEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428746644OSSEOUS PVA Eye Drain EON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428746651OSSEOUS PVA Eye Drain LargeEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428746668OSSEOUS PVA Eye WickEON MEDITECH PRIVATE LIMITEDKCN2024-07-05