Stratus Pharmaceuticals, Inc.

Basic Information

• Brand Name: Stratus Pharmaceuticals, Inc.
• Primary DI: 00358980780505
• Version / Model: 780-50
• Company Name: Stratus Pharmaceuticals, Inc.
• Labeler DUNS: 789001641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-10
• Public Version: 2
• Public Version Date: 2025-11-19
• Public Version Status: Update
• Public Device Record Key: 8c07c314-d9d7-498b-9893-ff12ce16d199

Device Description

Venelex 5gm/60ct UD dressing, wound, occlusive

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	878.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62069	Skin semi-occlusive dressing, non-antimicrobial	A substance (e.g., gel, ointment) intended to be topically applied to injured/diseased skin to expedite healing and re-epithelialization primarily through semi-occlusive properties which reduce moisture transmission from the skin to the environment by means of a physical barrier; it may also prevent abnormal scar formation and does not include an antimicrobial agent(s). It is intended for home/healthcare facility use to treat open skin wounds and/or conditions such as lacerations, burns, surgical wounds, radiation dermatitis, and inflammation. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00358980780505	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 68 – 77 Degrees Fahrenheit