Identity
- Trade Name
- DISPOSABLE REGULAR MARKING PENS 10/BOX FDA UDI
- Generic Name
- Skin marking pen, single-use FDA UDI
- Device Name
- DISPOSABLE REGULAR MARKING PENS 10/BOX FDA UDI
- Model / Reference
- AS-1583N FDA UDI
- Description
- DISPOSABLE REGULAR MARKING PENS 10/BOX FDA UDI
Identifiers
- Catalog Number
- AS-1583N FDA UDI
- Primary DI / UDI-DI
- 00841668142974 FDA UDI
- FDA Product Code
- HRP FDA UDI
- GMDN Term
- Skin marking pen, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4570 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Skin marking pen, single-use
Disposable Regular Marking Pens 10/Box by Katena Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin marking pen, single-use.
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- 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 |
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Manufacturer
- Manufacturer
- Katena Products, Inc.
Sources (1)
- FDA UDI 9623b6bd-a578-47ca-8533-6b9fa65bba9e 35 fields · synced Jun 12, 2026