Identity
- Trade Name
- VISICOIL FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- 0.35 mm x 2 cm VISICOIL FDA UDI
- Model / Reference
- FP-0010 FDA UDI
- Description
- 0.35 mm x 2 cm VISICOIL FDA UDI
Identifiers
- Catalog Number
- FP-0010 FDA UDI
- Primary DI / UDI-DI
- EIBAFP00100 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- Radiological image marker, implantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
MR Conditional FDA UDI
Visicoil by Izi Medical Products Llc — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Izi Medical Products Llc
Sources (1)
- FDA UDI 50c90d62-5d17-4f2c-aa29-ade09a504ab9 36 fields · synced May 31, 2026