G4Derm Plus Synthetic Wound Matrix

GUDID 00850058790008

Gel4med, Inc.

Synthetic wound matrix dressing

• Primary Device ID: 00850058790008
• NIH Device Record Key: f82f056d-b367-4a25-b225-746bac720a4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G4Derm Plus Synthetic Wound Matrix
• Version Model Number: 2 mL Pre Filled Syringe (Sterile)
• Company DUNS: 079722830
• Company Name: Gel4med, 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: 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	00850058790008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222025

FDA Product Code

• KGN: Wound Dressing With Animal-Derived Material(S)

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: 2024-03-21
• Device Publish Date: 2024-03-13

On-Brand Devices [G4Derm Plus Synthetic Wound Matrix]

• 00850058790022: Dispenser Box [Pre Filled Syringe (Sterile), Appli
• 00850058790015: Applicator Tip (Sterile)
• 00850058790008: 2 mL Pre Filled Syringe (Sterile)