Polynew

GUDID 26958868744018

Island dressing 10cm×10cm

Roosin Medical Co., Ltd.

Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad

• Primary Device ID: 26958868744018
• NIH Device Record Key: c6b03854-8974-4436-8ce7-c90e240a6cbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polynew
• Version Model Number: 10cm×10cm
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16958868744011 [Primary]
GS1	26958868744018 [Package]; Contains: 16958868744011; Package: box [12 Units]; In Commercial Distribution
GS1	36958868744015 [Package]; Package: box [30 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: 2022-10-03
• Device Publish Date: 2022-09-23

On-Brand Devices [Polynew]

• 26958868748023: Silicone Foam Dressing 10cm×10cm
• 16958868746015: Silver Calcium Alginate Dressing 10cm×10cm
• 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