PRIMASEAL Post-Op Ag MSCPS615

GUDID 10193489020182

Silver Surgical Hydrocolloid (SSHCD)

ADVANCED MEDICAL SOLUTIONS LIMITED

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 10193489020182
• NIH Device Record Key: 4e8a6315-0fe4-40bf-9cf8-227fa950fe96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIMASEAL Post-Op Ag
• Version Model Number: Ag Postoperative Ionic Silver
• Catalog Number: MSCPS615
• Company DUNS: 770434090
• Company Name: ADVANCED MEDICAL SOLUTIONS 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: true
• Single Use: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10193489020182 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180634

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: 2023-04-14
• Device Publish Date: 2023-04-06

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