FDA.reportPublic FDA data

OSSEOUS PVA Corneal Light Shield

Primary DI
08904428722686
Brand
OSSEOUS PVA Corneal Light Shield
Company
EON MEDITECH PRIVATE LIMITED
Model
E7144
Device description
A sterile compressed PVA sponge spear is used to absorb excess fluids from the corneal / scleral surface or to manipulate tissue during an ophthalmic surgical procedure. A PVA sponge is particularly preferred in the LASIK laser surgery due to a very soft cell structure when wet
Published
2024-07-05
Public version status
New
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
KCNEar Wick

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08904428746613PackageGS120In Commercial Distribution
08904428722686PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904428746613089044287466138904428746613
08904428722686089044287226868904428722686

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
930270428
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08904428721399OSSEOUS- Skin Closure TapeEA910662026-03-13
08904428721405OSSEOUS- Skin Preparation PadEA910622026-03-13
08904428744916OSSEOUS- ShowerProtectEA910512026-03-13
08904428744947OSSEOUS- NeckFit Tube HolderEA910532026-03-13
08904428744954OSSEOUS- Tube Cleaning Brush - 8mmEA910712026-03-13
08904428744992OSSEOUS-Cleaning PadEA910612026-03-13
08904428745012OSSEOUS- Adhesion Remover PadEA910632026-03-13
08904428745067OSSEOUS- TouchFree HME Series - StandardEA9100112026-03-13
08904461000499OSSEOUS-Heat Moisture Exchanger-AirEA910012026-03-13
08904461028783OSSEOUS- Shaver Blade Tube E2120-012026-03-13
08904461031080OSSEOUS-Ear/Nasal ExtractorE31492026-03-13
08904461055031OSSEOUS-SnorOFFE317012026-03-13
08904461055697OSSEOUS-CapsuleEA9100182026-03-13
00890446104932OSSEOUS-Endoscrub 4 mm ( 0° )EI29012026-03-13
08904428745326OSSEOUS- Skin Closure TapeEA910662026-03-13
08904428745333OSSEOUS- Skin Preparation PadEA910622026-03-13
08904428798421OSSEOUS- ShowerProtectEA910512026-03-13
08904428798438OSSEOUS- NeckFit Tube HolderEA910532026-03-13
08904428798483OSSEOUS- Tube Cleaning Brush - 8mmEA910712026-03-13
08904428798469OSSEOUS-Cleaning PadEA910612026-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08906038452922SURGI-PVA™- Ear PackAEGIS LIFESCIENCES PRIVATE LIMITEDKCN2026-08-21
08906038452939SURGI-PVA™- Ear PackAEGIS LIFESCIENCES PRIVATE LIMITEDKCN2026-08-21
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
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