Polynew

GUDID 26958868743042

Hydrocolloid dressing 5cm×5cm

Roosin Medical Co., Ltd.

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

• Primary Device ID: 26958868743042
• NIH Device Record Key: 3879f4f3-e9ec-4a02-a2a4-104903f10f12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polynew
• Version Model Number: 5cm×5cm
• Company DUNS: 527587815
• Company Name: Roosin Medical Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16958868743045 [Primary]
GS1	26958868743042 [Package]; Contains: 16958868743045; Package: box [20 Units]; In Commercial Distribution
GS1	36958868743049 [Package]; Package: box [110 Units]; In Commercial Distribution

FDA Product Code

• NAC: Dressing, Wound, Hydrophilic

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: 2024-05-21
• Device Publish Date: 2024-05-13

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• 26958868744018: Island dressing 10cm×10cm
• 26958868743011: Hydrocolloid Wound Dressing 10cm×10cm
• 26958868742090: Honey Calcium Alginate Dressing 5cm×5cm
• 26958868742014: Honey Gauze Dressing 5cm×5cm
• 26958868741017: Foam Dressing 10cm×10cm
• 26958868740010: Calcium Alginate Wound Dressing 10cm×10cm
• 26958868742175: Honey Gauze Dressing 10cm×10cm
• 26958868747057: Xeroform Petrolatum Dressing 5cm×5cm
• 26958868747040: Xeroform Petrolatum Dressing 2.5cm×20cm
• 26958868743059: Hydrocolloid dressing 5cm×7.5cm
• 26958868743042: Hydrocolloid dressing 5cm×5cm