OSSEOUS PVA LASIK Eye Drain

GUDID 08904428746637

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 ID: 08904428746637
• NIH Device Record Key: 9383d446-2de6-48ad-8f6a-509f6840bee6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSEOUS PVA LASIK Eye Drain
• Version Model Number: E7146
• Company DUNS: 930270428
• Company Name: EON MEDITECH PRIVATE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 40 Millimeter
• Width: 14 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 40 Millimeter
• Width: 14 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 40 Millimeter
• Width: 14 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 40 Millimeter
• Width: 14 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 40 Millimeter
• Width: 14 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 40 Millimeter
• Width: 14 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 40 Millimeter
• Width: 14 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 40 Millimeter
• Width: 14 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 40 Millimeter
• Width: 14 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 40 Millimeter
• Width: 14 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 40 Millimeter
• Width: 14 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 40 Millimeter
• Width: 14 Millimeter
• Outer Diameter: 10.5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08904428722709 [Primary]
GS1	08904428746637 [Package]; Contains: 08904428722709; Package: Laminated Box [20 Units]; In Commercial Distribution

FDA Product Code

• KCN: Ear Wick

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-15
• Device Publish Date: 2024-07-05

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