Xeroform Petrolatum Dressings

GUDID 00840117324244

3% Bismuth Tribromophenate in a petrolatum blend Med-High Absorbency For wound stages 2,3,4

DYNAREX CORPORATION

Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: 00840117324244
• NIH Device Record Key: ef85b13d-74d0-442e-82d2-7604f75709c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xeroform Petrolatum Dressings
• Version Model Number: 3042
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840117324237 [Package]; Package: Box [12 Units]; In Commercial Distribution
GS1	00840117324244 [Primary]
GS1	00840117324251 [Package]; Contains: 00840117324237; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152970

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: 2022-09-14
• Device Publish Date: 2022-09-06

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