BLASTX®

Basic Information

• Brand Name: BLASTX®
• Primary DI: 04260056880643
• Version / Model: WG-0001
• Catalog Number: MC-WG.0001-12
• Company Name: OSARTIS GmbH
• Labeler DUNS: 344261631
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-19
• Public Version: 1
• Public Version Date: 2026-02-27
• Public Version Status: New
• Public Device Record Key: 7f7e4641-51af-4bfc-b78c-42c422f3b700

Device Description

BLASTX® Next Science Wound Gel is a hydrogel that helps to maintain a moist wound environment that is conducive to healing. It is indicated for the management of wounds such as Stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites.

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
59522	Wound hydrogel dressing, antimicrobial	A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, 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 and gases. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14260056880640	GS1	Carton box	12	In Commercial Distribution
Primary	04260056880643	GS1

Premarket Submissions

Submission Number	Supplement Number
K163188	000

Device Sizes

Type	Value	Unit	Text
Total Volume	30	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius