Identity
- Trade Name
- DeRoyal FDA UDI
- Generic Name
- Skin marking pen, single-use FDA UDI
- Device Name
- ANGIO WHITE LBL KIT W/MARKER FDA UDI
- Model / Reference
- 77-400566 FDA UDI
- Description
- ANGIO WHITE LBL KIT W/MARKER FDA UDI
Identifiers
- Catalog Number
- 77-400566 FDA UDI
- Primary DI / UDI-DI
- 00749756615600 FDA UDI
- FDA Product Code
- KDD FDA UDI
- GMDN Term
- Skin marking pen, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Skin marking pen, single-use
DeRoyal by Deroyal Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin marking pen, single-use.
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- WriteSite® Jr. Small Preoperative Skin Marker — Aspen Surgical Products, Inc. · Class I
- NS10402 Correct Site Marker(small); Gentian Violet Ink; In Dispenser Box(50/box) — XODUS MEDICAL, INC. · Class I
- Alleset — GRI Medical & Electronic Technology Co., Ltd. · Class I
- NSMKR7132 Dual Tip Skin Marker Gentian Reg & Fine Tip -PL — XODUS MEDICAL, INC. · Class I
- Richard-Allan® Utility Marker with Labels — Aspen Surgical Products, Inc. · Class I
- Richard-Allan® Fine Tip Utility Pen — Aspen Surgical Products, Inc. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Deroyal Industries, Inc.
Sources (1)
- FDA UDI e2ae9295-265a-4173-ae1f-f830442e6fff 35 fields · synced Jun 8, 2026