Stratus Pharmaceuticals, Inc.

GUDID 00358980780116

Venelex 1oz dressing, wound, occlusive

Stratus Pharmaceuticals, Inc.

Skin semi-occlusive dressing, non-antimicrobial

• Primary Device ID: 00358980780116
• NIH Device Record Key: 4ea7a409-b3fd-427e-9276-3c554561926a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stratus Pharmaceuticals, Inc.
• Version Model Number: 780-11
• Company DUNS: 789001641
• Company Name: Stratus Pharmaceuticals, 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: true
• 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 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00358980780116 [Primary]

FDA Product Code

• NAD: Dressing, Wound, Occlusive

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: 2025-11-19
• Device Publish Date: 2025-11-10

On-Brand Devices [Stratus Pharmaceuticals, Inc.]

• 00358980780505: Venelex 5gm/60ct UD dressing, wound, occlusive
• 00358980780215: Venelex 2oz dressing, wound, occlusive
• 00358980780116: Venelex 1oz dressing, wound, occlusive