BasaDrox Rx Wound Gel

Basic Information

• Brand Name: BasaDrox Rx Wound Gel
• Primary DI: 00315455956834
• Version / Model: FP1019-20
• Company Name: ALVIX LABORATORIES, LLC
• Labeler DUNS: 962445925
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-10
• Public Version: 1
• Public Version Date: 2020-03-18
• Public Version Status: New
• Public Device Record Key: dbc373b6-a258-4261-b3db-9da8d782dbc8

Device Description

BasaDrox Rx Wound Gel is a wound dressing hydrogel that helps maintain a moist wound environment that is conducive to healing by either absorbing or donating moisture and wound exudates.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• 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
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
47763	Wound hydrogel dressing, non-sterile	A non-sterile wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids/gases. Some types are intended to reduce hypertrophic/keloid scars by providing a barrier impermeable to liquids/gases to maintain a moist environment. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00315455956834	GS1

Premarket Submissions

Submission Number	Supplement Number
K162017	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius