Identity
- Trade Name
- XCELLARISPRO barrier sleeve FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- VK-5700-001.01 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- VK-5700-001.01 FDA UDI
- Primary DI / UDI-DI
- 04260446131058 FDA UDI
- 510(k) Number
- K241790 FDA UDI
- FDA Product Code
- QAI FDA UDI
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4430 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical equipment/instrument drape, single-use
XCELLARISPRO barrier sleeve by Dermaroller GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dermaroller GmbH
Sources (1)
- FDA UDI 7f1cca70-7c98-49db-89f2-ebef3cfcbf83 35 fields · synced Jun 1, 2026