Field Shield Rx Wound Dressing,1oz spray 6510-01-727-1966

GUDID 00858071004843

Topical burn and wound dressing, hydrogel barrier antimicrobial with silver and lidocaine, Rx indications, 1oz spray

Kericure Inc.

Wound hydrogel dressing, antimicrobial

• Primary Device ID: 00858071004843
• NIH Device Record Key: b2856436-033f-4024-bb1c-ef965148cfe1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Field Shield Rx Wound Dressing,1oz spray
• Version Model Number: 5031610 or 5031910
• Catalog Number: 6510-01-727-1966
• Company DUNS: 966638681
• Company Name: Kericure Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00858071004843 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212521

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-03
• Device Publish Date: 2025-08-26

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