First Honey Sterile Honey Ointment (1.0 Oz)

GUDID 00854056008004

MANUKAMED LIMITED PARTNERSHIP

Medical-honey liquid barrier dressing, sterile Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial

• Primary Device ID: 00854056008004
• NIH Device Record Key: 3d7908fb-12e8-4b5a-90e4-1de6f4c2d6b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: First Honey Sterile Honey Ointment (1.0 Oz)
• Version Model Number: FH0049
• Company DUNS: 594970245
• Company Name: MANUKAMED LIMITED PARTNERSHIP
• Device Count: 1
• DM Exempt: false
• 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: 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854056008004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092689

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2020-05-22
• Device Publish Date: 2020-05-14

On-Brand Devices [First Honey Sterile Honey Ointment (1.0 Oz)]

• 00854056008134: FH0049D
• 00854056008004: FH0049