FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925037410
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
7089-0859
Device description
Blu Ear Wick, 9 cm x 24 cm, Bacteriostatic
Published
2018-09-13
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
00821925030077PackageGS110Not in Commercial Distribution
00821925037410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925030077008219250300778219250300770821925030077
00821925037410008219250374108219250374100821925037410

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
00821925034013Expandacell708907302018-09-13
00821925034020Gyrus ACMI708909072018-09-13
00821925034037Gyrus ACMI708909082018-09-13
00821925034532Gyrus ACMI8909112018-09-13
00821925037069Rhino Rocket708907292018-09-13
00821925037076Rhino Rocket708907312018-09-13
00821925037090Gyrus ACMI708907332018-09-13
00821925037106SlimLine708907342018-09-13
00821925037113Gyrus ACMI708907352018-09-13
00821925037120Gyrus ACMI708907372018-09-13
00821925037137Gyrus ACMI708907382018-09-13
00821925037144Gyrus ACMI708907392018-09-13
00821925037151Gyrus ACMI708907402018-09-13
00821925037168Gyrus ACMI708907412018-09-13
00821925037175Gyrus ACMI708907422018-09-13
00821925037182Gyrus ACMI708907432018-09-13
00821925037199Gyrus ACMI708907502018-09-13
00821925037205Gyrus ACMI708907512018-09-13
00821925037212Gyrus ACMI708907522018-09-13
00821925037229Gyrus ACMI708907532018-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20763000888927MerocelMEDTRONIC XOMED, INC.KCN2026-02-15
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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