MANUKAhd Lite 5 x 5 cm

GUDID 05060188820574

MANUKAMED LIMITED PARTNERSHIP

Exudate-absorbent dressing, non-gel, antimicrobial, sterile

• Primary Device ID: 05060188820574
• NIH Device Record Key: aae26ea0-5a7a-469d-95e0-c0d4d32fd39d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MANUKAhd Lite 5 x 5 cm
• Version Model Number: MM0013
• Company DUNS: 594970245
• Company Name: MANUKAMED LIMITED PARTNERSHIP
• Device Count: 10
• 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	05060188820574 [Unit of Use]
GS1	05060188820581 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102659

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 [MANUKAhd Lite 5 x 5 cm]

• 05060188820574: MM0013
• 05060188820055: MM0030