CELLUTOME™

GUDID 00849554001213

Cellutome Epidermal Harvesting System Harvester (2.5cm)

KCI USA, INC.

Dermatome, line-powered

• Primary Device ID: 00849554001213
• NIH Device Record Key: c2735efc-d056-47cd-93c6-6c2ff9ba26b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CELLUTOME™
• Version Model Number: CT-H25
• Company DUNS: 102726734
• Company Name: KCI USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00849554001190 [Package]; Package: 5 PACK [5 Units]; In Commercial Distribution
GS1	00849554001213 [Primary]

FDA Product Code

• GFD: Dermatome

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-03
• Device Publish Date: 2016-09-24

On-Brand Devices [CELLUTOME™ ]

• 00849554004078: Cellutome Harvester Strap Extension
• 00849554002968: Cellutome Epidermal Harvesting System Control Unit and Vacuum Head
• 00849554001985: 3M Tegaderm Film
• 00849554001220: Cellutome Epidermal Harvesting System Harvester (5.0cm)
• 00849554001213: Cellutome Epidermal Harvesting System Harvester (2.5cm)
• 00849554001176: Cellutome Epidermal Harvesting System Control Unit Stand