NU-GEL® MNG415U

GUDID 25051978010002

Hydrogel with Alginate

SYSTAGENIX WOUND MANAGEMENT, LIMITED

Wound hydrogel dressing, sterile

• Primary Device ID: 25051978010002
• NIH Device Record Key: 938aede6-f550-40ec-96a8-b53484c26866
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NU-GEL®
• Version Model Number: MNG415U
• Catalog Number: MNG415U
• Company DUNS: 211352227
• Company Name: SYSTAGENIX WOUND MANAGEMENT, LIMITED
• 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 Dimensions

• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051978010005 [Primary]
GS1	25051978010002 [Package]; Contains: 15051978010005; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• NAE: Dressing, Wound, Hydrogel Without Drug And/Or Biologic

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: 2019-10-02
• Device Publish Date: 2019-09-24

On-Brand Devices [NU-GEL®]

• 25051978010019: Hydrogel with Alginate
• 25051978010002: Hydrogel with Alginate