Celluheal

GUDID 00850048866959

SkinTemp sterile collagen wound dressing, 5x10 sheet

Human Biosciences Inc.

Collagen wound matrix dressing

• Primary Device ID: 00850048866959
• NIH Device Record Key: 599a0248-19e9-4d5b-bc45-dabbbef08bdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Celluheal
• Version Model Number: CS10510
• Company DUNS: 014511541
• Company Name: Human Biosciences 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850048866942 [Primary]
GS1	00850048866959 [Package]; Contains: 00850048866942; Package: [10 Units]; In Commercial Distribution

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: 2025-06-24
• Device Publish Date: 2025-06-16

On-Brand Devices [Celluheal]

• 00850048866041: Cellufil sterile collagen particles, 1 gram pouch
• 00850048866300: Cellusheet sterile collagen wound dressing, 2x2 sheet
• 00850048866959: SkinTemp sterile collagen wound dressing, 5x10 sheet