OSSEOUS PVA Eye Drain Large

GUDID 08904428746651

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 ID08904428746651
NIH Device Record Key765a7a0b-42f6-423c-b551-53100e243a9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSSEOUS PVA Eye Drain Large
Version Model NumberE7148
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

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
GS108904428722723 [Primary]
GS108904428746651 [Package]
Contains: 08904428722723
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

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