Skinsafe Plus Ag FT650666

GUDID 05060786987549

Skinsafe Plus Ag 120 5x5

SPECIALITY FIBRES AND MATERIALS LIMITED

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 05060786987549
• NIH Device Record Key: e8fb53b1-0bad-4c1b-b783-fafdfe61004f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Skinsafe Plus Ag
• Version Model Number: Skinsafe Plus Ag 120 5x5
• Catalog Number: FT650666
• Company DUNS: 219041423
• Company Name: SPECIALITY FIBRES AND MATERIALS LIMITED
• 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: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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	05060786987549 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183208

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: 2023-11-22
• Device Publish Date: 2023-11-14

On-Brand Devices [Skinsafe Plus Ag]

• 05060786987556: Skinsafe Plus Ag 120 10x12.5
• 05060786987549: Skinsafe Plus Ag 120 5x5