XCELLARISPRO barrier sleeve VK-5700-001.01

GUDID 04260446131102

BARRIER SLEEVE for Microneedling Device The XCELLARISPRO barrier sleeve is a disposable consumable that is to be used with the XCELLARISPRO microneedling system. It covers the handpiece during each patient use to minimize the risk of cross-contamination. It is a single-use, non-sterile device.

Dermaroller GmbH

Medical equipment/instrument drape, single-use

• Primary Device ID: 04260446131102
• NIH Device Record Key: 7f1cca70-7c98-49db-89f2-ebef3cfcbf83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XCELLARISPRO barrier sleeve
• Version Model Number: VK-5700-001.01
• Catalog Number: VK-5700-001.01
• Company DUNS: 341978822
• Company Name: Dermaroller GmbH
• Device Count: 25
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260446131058 [Primary]
GS1	04260446131102 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241790

FDA Product Code

• QAI: Powered Microneedle Device

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: 2025-09-03
• Device Publish Date: 2025-08-26

Devices Manufactured by Dermaroller GmbH

• 04260446131102 - XCELLARISPRO barrier sleeve: 2025-09-03BARRIER SLEEVE for Microneedling Device The XCELLARISPRO barrier sleeve is a disposable consumable that is to be used with the XCELLARISPRO microneedling system. It covers the handpiece during each patient use to minimize the risk of cross-contamination. It is a single-use, non-sterile device.
• 04260446131102 - XCELLARISPRO barrier sleeve: 2025-09-03 BARRIER SLEEVE for Microneedling Device The XCELLARISPRO barrier sleeve is a disposable consumable that is to be used with the X
• 04260446131065 - XCELLARISPRO TWIST microneedling device: 2025-09-03 A microneedling device for aesthetic using one or more needles to mechanically puncture and injure skin tissue for aesthetic use
• 04260446131072 - XCELLARISPRO TWIST Control unit: 2025-09-03 The control unit is one component of the XCELLARISPRO TWIS microneedling system.
• 04260446131089 - XCELLARISPRO TWIST Handpiece: 2025-09-03 XCELLARISPRO TWIST Handpiece is a component of the XCELLARISPRO TWIST microneedling system
• 04260446136268 - XCELLARISPRO Needling Module: 2025-09-03 XCELLARISPRO Needling Modules for Microneedling Device The needling module is a consumable to be used with the XCELLARISPRO micr