AVITA

GUDID 10810125742641

Stedical Scientific, Inc.

Collagen wound matrix dressing

• Primary Device ID: 10810125742641
• NIH Device Record Key: c4f55dca-1ae0-417b-a180-f6c814d1b11c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVITA
• Version Model Number: PDG MED
• 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	00810125742644 [Primary]
GS1	10810125742641 [Package]; Contains: 00810125742644; Package: Case [4 Units]; In Commercial Distribution
GS1	20810125742648 [Unit of Use]

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: 2024-09-04
• Device Publish Date: 2024-08-27

On-Brand Devices [AVITA]

• 10810125742665: PDG XL
• 10810125742658: PDG LG
• 10810125742641: PDG MED
• 10810125742634: PDG SM
• 10810125742627: PDG XS
• 10810125742610: PDB 5x10
• 10810125742153: PDB 10x15
• 10810125742122: PDB 15x30
• 10810125742092: PDC 2.5 x 5
• 10810125741408: PDC 2.5 x 2.5
• 10810125741378: PDC 5x5