FORM FIT® Hydrogel Canalicular Plug

GUDID 10845819000271

Form Fit® Hydrogel Canalicular Plug in Squeeze Inserter

OASIS MEDICAL, INC.

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

Devices Manufactured by OASIS MEDICAL, INC.

• 00845819020111 - Surgeon's Choice Card: 2024-11-15 Kit Packs Assembled from Non-Sterile Capped Product: 2 Anterior Chamber Cannula, 27g x 7/8" (0.4 x 22mm), 8mm Bend (GTIN: 008458
• 10845819020118 - Surgeon's Choice Card: 2024-11-15 Kit Packs Assembled from Non-Sterile Capped Product. For Bulk Packaging 20 kit packs are loaded into one carton Each kit pack co
• 10845819002916 - Premier Edge® Microsurgical Knives: 2024-01-08 2.85mm Clear Cornea Knife, Safety Line
• 10845819002923 - Premier Edge® Microsurgical Knives: 2024-01-08 Microsurgical Knife 1.8 mm Slit Knife
• 00845819002971 - Surgeon's Choice Card: 2024-01-04 Kit Packs Assembled from Non-Sterile Capped Product: 2 eaches of Anterior Chamber Cannula, 27g x 7/8'', 8mm Bend (GTIN:008458190
• 10845819002985 - Surgeon's Choice Card: 2024-01-04 Kit Packs Assembled from Non-Sterile Capped Product: 2 eaches of Anterior Chamber Cannula, 27g x 7/8'', 8mm Bend (GTIN:008458190
• 00845819002322 - Premier Edge® Microsurgical Knives: 2023-10-23 2.75mm Thin Slit Knife, Microsurgical Knife
• 00845819000267 - SOFT PLUG® Extended Duration Plugs: 2023-08-08 SOFT PLUG® Extended Duration Plug Variety Pack 20 Plugs Assorted: 2 eaches of 0.2mm DIA x 2mm Long (GTIN: 00845819000212) 6 eac