OSSEOUS PVA Corneal Light Shield

GUDID 08904428746590

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

EON MEDITECH PRIVATE LIMITED

Ophthalmic sponge
Primary Device ID08904428746590
NIH Device Record Keyb7da4669-abbf-4b80-b2c8-cd081da77b15
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSSEOUS PVA Corneal Light Shield
Version Model NumberE7142
Company DUNS930270428
Company NameEON MEDITECH PRIVATE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Height7 Millimeter
Height7 Millimeter
Height7 Millimeter
Height7 Millimeter
Height7 Millimeter
Height7 Millimeter
Height7 Millimeter
Height7 Millimeter
Height7 Millimeter
Height7 Millimeter
Height7 Millimeter
Height7 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108904428722662 [Primary]
GS108904428746590 [Package]
Contains: 08904428722662
Package: Laminated Box [20 Units]
In Commercial Distribution

FDA Product Code

KCNEar Wick

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-15
Device Publish Date2024-07-05

On-Brand Devices [OSSEOUS PVA Corneal Light Shield ]

08904428746613A sterile compressed PVA sponge spear is used to absorb excess fluids from the corneal / scleral
08904428746606A sterile compressed PVA sponge spear is used to absorb excess fluids from the corneal / scleral
08904428746590A sterile compressed PVA sponge spear is used to absorb excess fluids from the corneal / scleral

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