Identity
- Trade Name
- VISICOIL FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- 2 - 0.75mm x 0.50cm VISICOIL separated by a 20mm PGLA spacer (Non-Stranded) loaded in an 18 gauge pre-waxed brachytherapy needle 20cm in length. FDA UDI
- Model / Reference
- TL-075-62018 FDA UDI
- Description
- 2 - 0.75mm x 0.50cm VISICOIL separated by a 20mm PGLA spacer (Non-Stranded) loaded in an 18 gauge pre-waxed brachytherapy needle 20cm in length. FDA UDI
Identifiers
- Catalog Number
- TL-075-62018 FDA UDI
- Primary DI / UDI-DI
- EIBATL075620180 FDA UDI
- 510(k) Number
- K120859 FDA UDI
- FDA Product Code
- KXK FDA UDI
- GMDN Term
- Radiological image marker, implantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5730 FDA UDI
- Commercial Distribution
- 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
Ethylene Oxide FDA UDI
MR Conditional FDA UDI
Category: Radiological image marker, implantable
Visicoil by Izi Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- AutoMark — M.D.L. S.R.L. · Class I
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Cleared under the same submission
K120859 also covers:
- VISICOIL — IZI MEDICAL PRODUCTS LLC
- VISICOIL — IZI MEDICAL PRODUCTS LLC
- VISICOIL — IZI MEDICAL PRODUCTS LLC
- VISICOIL — IZI MEDICAL PRODUCTS LLC
- VISICOIL — IZI MEDICAL PRODUCTS LLC
- VISICOIL — IZI MEDICAL PRODUCTS LLC
- VISICOIL — IZI MEDICAL PRODUCTS LLC
- VISICOIL — IZI MEDICAL PRODUCTS LLC
- VISICOIL — IZI MEDICAL PRODUCTS LLC
- VISICOIL — IZI MEDICAL PRODUCTS LLC
- VISICOIL — IZI MEDICAL PRODUCTS LLC
- VISICOIL — IZI MEDICAL PRODUCTS LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Izi Medical Products Llc
Sources (1)
- FDA UDI 60e55603-e3d4-4654-b734-51d13f6fc63e 36 fields · synced May 30, 2026