FORM FIT® Hydrogel Canalicular Plug

GUDID 10845819000271

Form Fit® Hydrogel Canalicular Plug in Squeeze Inserter

OASIS MEDICAL, INC.

Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug

• Primary Device ID: 10845819000271
• NIH Device Record Key: b286fdb4-feb5-494c-b549-b24547fbe30b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FORM FIT® Hydrogel Canalicular Plug
• Version Model Number: 6303, 6303-T, B-6303
• Company DUNS: 194121018
• Company Name: OASIS MEDICAL, INC.
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845819000274 [Primary]
GS1	10845819000271 [Package]; Contains: 00845819000274; Package: Carton [10 Units]; In Commercial Distribution
GS1	20845819000278 [Package]; Contains: 00845819000274; Package: Carton [2 Units]; In Commercial Distribution
GS1	30845819000275 [Package]; Contains: 00845819000274; Package: Plastic Bag [100 Units]; In Commercial Distribution

FDA Product Code

• LZU: Plug, Punctum

Sterilization

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

[10845819000271]

Radiation Sterilization

[10845819000271]

Radiation Sterilization

[10845819000271]

Radiation Sterilization

[10845819000271]

Radiation Sterilization

[10845819000271]

Radiation Sterilization

[10845819000271]

Radiation Sterilization

[10845819000271]

Radiation Sterilization

[10845819000271]

Radiation Sterilization

[10845819000271]

Radiation Sterilization

[10845819000271]

Radiation Sterilization

[10845819000271]

Radiation Sterilization

[10845819000271]

Radiation Sterilization

[10845819000271]

Radiation Sterilization

[10845819000271]

Radiation Sterilization

[10845819000271]

Radiation Sterilization

[10845819000271]

Radiation Sterilization

[10845819000271]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-10
• Device Publish Date: 2023-06-30

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