Reso-Pac Hydrophilic Periodontal Dressing

GUDID D2481550190

HAGER WORLDWIDE, INC.

General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived

• Primary Device ID: D2481550190
• NIH Device Record Key: 7a2ff104-011a-453c-b5fa-afdcd9731cc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reso-Pac Hydrophilic Periodontal Dressing
• Version Model Number: 155019
• Company DUNS: 009277971
• Company Name: HAGER WORLDWIDE, INC.
• Device Count: 50
• 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: false
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D2481550190 [Primary]
HIBCC	D2481550191 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050648

FDA Product Code

• EMA: Cement, Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-05-27
• Device Publish Date: 2016-09-22

On-Brand Devices [Reso-Pac Hydrophilic Periodontal Dressing]

• D2481550190: 155019
• D2481550180: 155018