Identity
- Trade Name
- Key Surgical Skin Markers FDA UDI
- Generic Name
- Skin marking pen, single-use FDA UDI
- Device Name
- Skin Markers, Sterile, Dual tip (1 mm and 0.5 mm) with Ruler and 6 labels FDA UDI
- Model / Reference
- SM-300 FDA UDI
- Description
- Skin Markers, Sterile, Dual tip (1 mm and 0.5 mm) with Ruler and 6 labels FDA UDI
Identifiers
- Catalog Number
- SM300 FDA UDI
- Primary DI / UDI-DI
- 00849771030485 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
- Not 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Key Surgical Skin Markers by Key Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Key Surgical, LLC
Sources (1)
- FDA UDI d11f55e4-c124-4f8c-885f-f4c77e3687c1 36 fields · synced Jun 8, 2026