FDA.reportPublic FDA data

OSSEOUS PVA LASIK EYE

Primary DI
08904428722754
Brand
OSSEOUS PVA LASIK EYE
Company
EON MEDITECH PRIVATE LIMITED
Model
E7151
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
08904428746682PackageGS120In Commercial Distribution
08904428722754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904428746682089044287466828904428746682
08904428722754089044287227548904428722754

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic spongeA device made of absorbent material, e.g., gauze, cotton or cellulose, intended to be used to absorb excess fluid produced by the eye during microsurgical procedures and ophthalmic surgery such as cataract surgery and laser assisted in situ keratomileusis (LASIK) procedures. Some types can be used as an eyelid and lash guard and are typically shaped for use in conjunction with an eye speculum. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter9Millimeter
Width7Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 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
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
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
08904428746675OSSEOUS PVA Eye Wick and WipeEON MEDITECH PRIVATE LIMITEDKCN2024-07-05