Milliken

GUDID 10810125741972

Stedical Scientific, Inc.

Collagen wound matrix dressing

• Primary Device ID: 10810125741972
• NIH Device Record Key: 7d318ab7-a502-4aa2-8c39-b5ff1793723d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Milliken
• Version Model Number: PDB 10x15
• Company DUNS: 117174392
• Company Name: Stedical Scientific, Inc.
• Device Count: 3
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00810125741975 [Primary]
GS1	10810125741972 [Package]; Contains: 00810125741975; Package: Case [4 Units]; In Commercial Distribution
GS1	20810125741979 [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: 2023-03-01
• Device Publish Date: 2023-02-21

On-Brand Devices [Milliken]

• 10810125742559: PDG XL
• 10810125742542: PDG LG
• 10810125742535: PDG MED
• 10810125742528: PDG SM
• 10810125742511: PDG XS
• 10810125742009: PDB 15x30
• 10810125741972: PDB 10x15
• 10810125741941: PDB 5x10