BLASTX® MC-WG.0001-12

GUDID 14260056880640

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.

OSARTIS GmbH

Wound hydrogel dressing, antimicrobial

• Primary Device ID: 14260056880640
• NIH Device Record Key: 7f7e4641-51af-4bfc-b78c-42c422f3b700
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLASTX®
• Version Model Number: WG-0001
• Catalog Number: MC-WG.0001-12
• Company DUNS: 344261631
• Company Name: OSARTIS GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260056880643 [Primary]
GS1	14260056880640 [Package]; Contains: 04260056880643; Package: Carton box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163188

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-27
• Device Publish Date: 2026-02-19

Devices Manufactured by OSARTIS GmbH

• 14260056880640 - BLASTX®: 2026-02-27BLASTX® 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.
• 14260056880640 - BLASTX®: 2026-02-27 BLASTX® Next Science Wound Gel is a hydrogel that helps to maintain a moist wound environment that is conducive to healing. It
• 04260056882579 - BonOs HV: 2024-05-27 BonOs® HV is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductil
• 04260056882623 - BonOs HV Genta: 2024-04-11 BonOs® HV Genta is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two sep
• 14260056880619 - EASYMIX® Nozzle slim: 2022-12-09 The vacuum mixing systems EASYMIX® is a mixing systems for PMMA bone cements, which are indicated to be used with a mixing syst
• 14260056880916 - EASYMIX® Nozzle revision: 2022-12-09 The vacuum mixing systems EASYMIX® is a mixing systems for PMMA bone cements, which are indicated to be used with a mixing syst
• 04260056881022 - EASYMIX® compressed air hose: 2022-12-09 EASYMIX® compressed air hose, 5 m, Medap wall coupling. The compressed air hoses connect the EASYMIX® vacuum pump to the compr
• 04260056881039 - EASYMIX® compressed air hose: 2022-12-09 EASYMIX® compressed air hose, 5 m, DIN 13260-2 wall coupling. Compressed air hoses connect the EASYMIX® vacuum pump to the com
• 04260056881633 - EASYMIX® vacuum pump I: 2022-12-09 The devices are used with an EASYMIX® vacuum mixing system to reduce air entrapment in bone cement. The pump is operated with c