Durma+ DynaGinate AG, Calcium Alginate Dressing, 4" x 4"

GUDID 00840117343689

Dynarex Corporation

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

• Primary Device ID: 00840117343689
• NIH Device Record Key: abad4c90-6799-431a-bfd4-b3027d519716
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Durma+ DynaGinate AG, Calcium Alginate Dressing, 4" x 4"
• Version Model Number: 3010
• Company DUNS: 008124539
• Company Name: Dynarex Corporation
• 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: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840117343689 [Primary]
GS1	00840117343696 [Package]; Package: Box [12 Units]; In Commercial Distribution
GS1	00840117343702 [Package]; Contains: 00840117343696; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192478

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-06
• Device Publish Date: 2025-05-29

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