Dynarex L-Mesitran Soft

GUDID 00616784307831

DYNAREX CORPORATION

Medical-honey liquid barrier dressing, non-sterile

• Primary Device ID: 00616784307831
• NIH Device Record Key: 0c4e9c1e-556d-4d01-8b05-2dfaee746836
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynarex L-Mesitran Soft
• Version Model Number: 3078
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 24
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784307817 [Unit of Use]
GS1	00616784307824 [Unit of Use]
GS1	00616784307831 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150676

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: 2019-06-11
• Device Publish Date: 2019-06-03

Devices Manufactured by DYNAREX CORPORATION

• 00840117329829 - LabChoice Pipette Filler Rechargeable for Serological Pipettes: 2025-04-25
• 00840117336414 - LabChoice 24-Hour Urine Collection Container, 3000 mL: 2025-04-25
• 00810180841726 - LabChoice Plastic Test Tubes, Polystyrene, 12 x 75 mm: 2025-04-25
• 00810180841733 - LabChoice Plastic Test Tubes, Polypropylene, 12 x 75 mm: 2025-04-25
• 00810180841740 - LabChoice Plastic Test Tubes, Polystyrene, 13 x 75 mm: 2025-04-25
• 00810180841757 - LabChoice Plastic Test Tubes, Polypropylene, 13 x 75 mm: 2025-04-25
• 00810180841764 - LabChoice Plastic Test Tubes, Polystyrene, 13 x 100 mm: 2025-04-25
• 00810180841771 - LabChoice Plastic Test Tubes, Polystyrene, 16 x 100 mm: 2025-04-25