Suprasorb P Sensitive Ag 180018

GUDID 04063591428321

L&R USA INC.

Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial

• Primary Device ID: 04063591428321
• NIH Device Record Key: a5867320-fae2-45bc-8fbe-7a8dc8f1a729
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Suprasorb P Sensitive Ag
• Version Model Number: 15cm x 15cm no border
• Catalog Number: 180018
• Company DUNS: 849081406
• Company Name: L&R USA INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	04063591428307 [Primary]
GS1	04063591428314 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	04063591428321 [Package]; Contains: 04063591428307; Package: Pouch [1 Units]; In Commercial Distribution
GS1	04063591428338 [Package]; Contains: 04063591428314; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160022

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: 2021-09-23
• Device Publish Date: 2021-09-15

On-Brand Devices [Suprasorb P Sensitive Ag]

• 04063591428376: 20cm x 20cm no border
• 04063591428321: 15cm x 15cm no border
• 04063591428291: 10cm x 12.5cm no border
• 04063591428246: 10cm x 10cm no border
• 04063591428208: 5cm x 5cm no border
• 04063591428154: 12.5cm x 12.5cm with border
• 04063591428116: 20cm x 20cm with border
• 04063591428079: 15cm x 15cm with border
• 04063591428031: 10cm x 10cm with border
• 04063591426150: 7.5cm x 7.5cm with border