PermeaDerm

GUDID 00856880007321

Stedical Scientific, Inc.

Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing

• Primary Device ID: 00856880007321
• NIH Device Record Key: ee3391b6-2b64-4e23-ae26-86d50202b39d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PermeaDerm
• Version Model Number: PDC 5x5
• Company DUNS: 117174392
• Company Name: Stedical Scientific, Inc.
• Device Count: 10
• 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	00856880007321 [Primary]
GS1	10856880007328 [Unit of Use]
GS1	20856880007325 [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: 2023-03-01
• Device Publish Date: 2023-02-21

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