GEMCORE360 AM-WC-HPDAG4475

GUDID 10610888002149

41-24AP Silver HPD

ADVANCED MEDICAL SOLUTIONS LIMITED

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 10610888002149
• NIH Device Record Key: 8635e316-b22e-4dcc-a9a0-fca2db775115
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEMCORE360
• Version Model Number: Silver Antimicrobial High Performance Dressing
• Catalog Number: AM-WC-HPDAG4475
• 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: true
• 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	10610888002149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183645

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: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [GEMCORE360 ]

• 10610888002170: Silicone PHMB Foam Border Dressings.
• 10610888002163: Silicone PHMB Foam Border Dressing.
• 10610888002156: 41-24AP Silver HPD
• 10610888002149: 41-24AP Silver HPD
• 10610888002132: 41-24AP Silver HPD
• 10610888002064: Hydrogel Tube 15g
• 10610888002057: Hydrogel Tube 8g
• 10610888000398: Hydrocolloid Foam Backed Dressing.
• 10610888000381: Hydrocolloid Foam Backed Dressings
• 10610888000374: Hydrocolloid Foam Backed Dressing.
• 10610888000367: Hydrocolloid Film Backed Dressings.
• 10610888000350: Hydrocolloid Film Backed Dressings
• 10610888000343: Hydrocolloid Film Backed Dressing.
• 10610888000336: PHMB Foam Non-Adhesive (Gamma)
• 10610888000329: PHMB Foam Non-Adhesive (Gamma)
• 10610888000312: PHMB Foam Adhesive
• 10610888000305: PHMB Foam Adhesive
• 10610888000299: Foam Lite Non Border
• 10610888000282: Foam Lite Non Border
• 10610888000275: Foam Lite Border
• 10610888000268: Foam Lite Border
• 10610888000251: Silicone Trilaminate Foam Non-Border
• 10610888000244: Silicone Trilaminate Foam Non-Border
• 10610888000237: Silicone Trilaminate Foam Non-Border
• 10610888000220: Silicone Trilaminate Foam Border
• 10610888000213: Silicone Trilaminate Foam Border
• 10610888000206: Silicone Trilaminate Foam Border
• 10610888000190: 41-21AP
• 10610888000183: 41-21AP
• 10610888000176: 41-21AP
• 10610888000169: 14-24DP Silver Alginate IV
• 10610888000152: 14-24DP Silver Alginate IV
• 10610888000145: 14-24DP Silver Alginate IV
• 10610888000138: 1-21DP Reinforced
• 10610888000121: 1-21DP Reinforced
• 10610888000114: 1-21DP Reinforced
• 10610888002071: Silver Gel Tube 45g, flowerpot