Epsilon

GUDID 05060165019137

Epsilon PVA Spears - Carton

NETWORK MEDICAL PRODUCTS LIMITED

Ophthalmic sponge

• Primary Device ID: 05060165019137
• NIH Device Record Key: 627ce58d-48c2-4b87-a50d-dee7e28ad0a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epsilon
• Version Model Number: E405
• Company DUNS: 458670304
• Company Name: NETWORK MEDICAL PRODUCTS LIMITED
• Device Count: 100
• DM Exempt: true
• Pre-market Exempt: false
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060165019137 [Primary]
GS1	05060165019144 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130117

FDA Product Code

• HOZ: Sponge, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-20
• Device Publish Date: 2019-08-28

On-Brand Devices [Epsilon]

• 05060165019175: Epsilon Cellulose Spears x 10 - Carton
• 05060165019151: Epsilon Cellulose Spears x 5 - Carton
• 05060165019137: Epsilon PVA Spears - Carton