Xeroform Petrolatum Dressings, 5"x9"

GUDID 00616784305417

3% Bismuth Tribromophenate in a petrolatum blend, Sterile

DYNAREX CORPORATION

Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: 00616784305417
• NIH Device Record Key: aaa5cced-2df3-4074-951c-ec1f1405e661
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xeroform Petrolatum Dressings, 5"x9"
• Version Model Number: 3054
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784305417 [Primary]
GS1	00616784305424 [Package]; Package: Box [50 Units]; In Commercial Distribution
GS1	00616784305431 [Package]; Contains: 00616784305424; Package: Case [4 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: 2022-10-11
• Device Publish Date: 2022-10-03

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