Identity
- Trade Name
- 10400 Correct Site Marker; Sharpie Style FDA UDI
- Generic Name
- Skin marking pen, single-use FDA UDI
- Device Name
- 10400 Correct Site Marker; Sharpie Style FDA UDI
- Model / Reference
- 10400 FDA UDI
- Description
- 10400 Correct Site Marker; Sharpie Style FDA UDI
Identifiers
- Catalog Number
- 10400 FDA UDI
- Primary DI / UDI-DI
- 00787551008210 FDA UDI
- FDA Product Code
- FZZ FDA UDI
- GMDN Term
- Skin marking pen, single-use FDA UDI
- Models / Variants
- 10400 Correct Site Marker FDA UDISharpie Style 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Skin marking pen, single-use
10400 Correct Site Marker - Sharpie Style by Xodus Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — 2 models — regulatory data on deviCERTS
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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
- Xodus Medical, Inc.
Sources (1)
- FDA UDI 31ec5920-01b5-4b53-aa3a-d308914e85cd 35 fields · synced Jun 8, 2026