Identity
- Trade Name
- Scanlan® Surgical skin markers FDA UDI
- Generic Name
- Skin marking pen, single-use, non-sterile FDA UDI
- Device Name
- Scanlan® Surgical skin markers - Regular Tip, Gentian Violet, BNS (10 per pkg) FDA UDI
- Model / Reference
- 1001-710B FDA UDI
- Description
- Scanlan® Surgical skin markers - Regular Tip, Gentian Violet, BNS (10 per pkg) FDA UDI
Identifiers
- Catalog Number
- 1001-710B FDA UDI
- Primary DI / UDI-DI
- 00846159029031 FDA UDI
- FDA Product Code
- FZZ FDA UDI
- GMDN Term
- Skin marking pen, single-use, non-sterile 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Skin marking pen, single-use, non-sterile
Scanlan® Surgical skin markers by Scanlan International Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Scanlan International Inc
Sources (2)
- FDA UDI 1d3e1e7d-90b5-4b1c-8814-f3489ee0bb55 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026