Dermagraft

GUDID 00618474000015

Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot.

ORGANOGENESIS INC.

Skin regeneration template, human-/animal-derived

• Primary Device ID: 00618474000015
• NIH Device Record Key: 17ff0e99-7199-44d1-b844-9bde6d4ca4e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dermagraft
• Version Model Number: 1
• Company DUNS: 152165817
• Company Name: ORGANOGENESIS 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: true
• 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

Customer Support Contacts

• Phone: 1-877-337-6247
• Email: xxx@xxx.xx
• Phone: 1-877-337-6247
• Email: xxx@xxx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between -85 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618474000015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BP003600

FDA Product Code

• PFC: Cultured Human Cell Skin Dressing

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: 2018-07-06
• Device Publish Date: 2014-09-24

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