PermeaDerm

GUDID 00856880007048

Stedical Scientific, Inc.

Collagen wound matrix dressing

• Primary Device ID: 00856880007048
• NIH Device Record Key: 9043bcb5-996a-47f6-b137-3496a01048e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PermeaDerm
• Version Model Number: PDG LG
• Company DUNS: 117174392
• Company Name: Stedical Scientific, Inc.
• Device Count: 2
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856880007048 [Primary]
GS1	10856880007045 [Unit of Use]
GS1	20856880007042 [Package]; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153678

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: 2023-02-28
• Device Publish Date: 2023-02-20

On-Brand Devices [PermeaDerm]

• 00856880007246: PDB 15x30
• 00856880007222: PDB 10x15
• 00856880007215: PDB 5x10
• 00856880007055: PDG XL
• 00856880007048: PDG LG
• 00856880007031: PDG MED
• 00856880007024: PDG SM
• 00856880007017: PDG XS
• 00856880007321: PDC 5x5