Apligraf

GUDID 00618474000008

Apligraf is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full thickness skin ulcers due to venous insufficience of greater than one month duration and which have not adequately responded to conventional ulcer therapy. Apligraf is also indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.

ORGANOGENESIS INC.

Skin regeneration template, human-/animal-derived

• Primary Device ID: 00618474000008
• NIH Device Record Key: df48bbf4-5d9d-461a-bc55-c3fa548b0a53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apligraf
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-432-5232
• Email: xxx@xx.xx
• Phone: 1-888-432-5232
• Email: xxx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do Not Open Bag Until Immediately Prior to Use
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Open Bag Until Immediately Prior to Use
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Open Bag Until Immediately Prior to Use
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Open Bag Until Immediately Prior to Use

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618474000008 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-24

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