PFAB Medium Crescent PFAB-MC

GUDID 00856525007389

Silicone Foam Dressing with Air Bolster

SUN SCIENTIFIC, INC.

Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial

• Primary Device ID: 00856525007389
• NIH Device Record Key: 5cf8588c-faea-448c-87e8-8e8090bc6b33
• Commercial Distribution Discontinuation: 2025-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PFAB Medium Crescent
• Version Model Number: PFAB-MC
• Catalog Number: PFAB-MC
• Company DUNS: 609397224
• Company Name: SUN SCIENTIFIC, INC.
• 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

Customer Support Contacts

• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856525007389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070457

FDA Product Code

• MHW: Dressing, Compression

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: 2021-05-10
• Device Publish Date: 2021-04-30

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