Nuvagen Collagen Dressing 1002

GUDID 10618474000524

Sterile, disposable, single-use collagen wound dressing (2"x2"). It is a hydrocolloid and hydrophilic dressing composed of fibrous type I bovine collagen.

Cpn Biosciences, LLC

Collagen wound matrix dressing

• Primary Device ID: 10618474000524
• NIH Device Record Key: 49a7c012-69c2-4e6a-9f81-3e1623b15f93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nuvagen Collagen Dressing
• Version Model Number: 1002
• Catalog Number: 1002
• Company DUNS: 079896008
• Company Name: Cpn Biosciences, LLC
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618474000527 [Primary]
GS1	10618474000524 [Package]; Contains: 00618474000527; Package: Box of 5 pouches [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122325

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: 2023-10-02
• Device Publish Date: 2023-09-22

Devices Manufactured by Cpn Biosciences, LLC

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• 00699923322506 - Nuvasorb (2"x2"): 2023-10-11 Surgical Sponges, 2"x2"
• 00699923342252 - Nuvasorb (4"x4"): 2023-10-11 Surgical sponge, 4"x4"
• 00618474000510 - Nuvagen Collagen Powder: 2023-10-02 A sterile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. Nuvagen Collagen Pow
• 10618474000524 - Nuvagen Collagen Dressing: 2023-10-02Sterile, disposable, single-use collagen wound dressing (2"x2"). It is a hydrocolloid and hydrophilic dressing composed of fibrous type I bovine collagen.
• 10618474000524 - Nuvagen Collagen Dressing: 2023-10-02 Sterile, disposable, single-use collagen wound dressing (2"x2"). It is a hydrocolloid and hydrophilic dressing composed of fibro
• 00699923012100 - Nuvafoam: 2023-10-02 Foam Dressing, 4" x 4.25"
• 00699923656502 - Nuvadhere: 2023-10-02 Waterproof adhesive tape, 1"x10 yds