Walcott

GUDID 20385640090005

Summit Medical, Inc.

Ophthalmic sponge

• Primary Device ID: 20385640090005
• NIH Device Record Key: 2b6bd1b3-b818-47e5-81ee-21aaf7205610
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Walcott
• Version Model Number: Rx40405
• Company DUNS: 965484699
• Company Name: Summit Medical, Inc.
• Device Count: 5
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385640090001 [Unit of Use]
GS1	10385640090008 [Primary]
GS1	20385640090005 [Package]; Contains: 10385640090008; Package: Box [40 Units]; In Commercial Distribution

FDA Product Code

• HOZ: Sponge, Ophthalmic

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: 2026-02-11
• Device Publish Date: 2026-02-03

On-Brand Devices [Walcott]

• 40385640090016: Rx40415
• 20385640090012: Rx40410
• 20385640090005: Rx40405