Identity
- Trade Name
- SANDEL FDA UDI
- Generic Name
- Skin marking pen, single-use FDA UDI
- Device Name
- SANDEL PETITE SKIN MARKER, BULK (NS) FDA UDI
- Model / Reference
- 1011-NNS FDA UDI
- Description
- SANDEL PETITE SKIN MARKER, BULK (NS) FDA UDI
Identifiers
- Catalog Number
- 1011-NNS FDA UDI
- Primary DI / UDI-DI
- 35414566830081 FDA UDI
- FDA Product Code
- FZZ FDA UDI
- GMDN Term
- Skin marking pen, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4660 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
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Radiation Sterilization FDA UDI
Category: Skin marking pen, single-use
Sandel by Ansell Sandel Medical Solutions LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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
- Ansell Sandel Medical Solutions LLC
Sources (1)
- FDA UDI a221c193-f7e6-4336-a7fd-5cbac295a8a3 35 fields · synced May 29, 2026