Identity
- Trade Name
- VISICOIL FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- 2 - 0.50mm x 0.5cm VISICOIL separated by a 15mm spacer (Non-Stranded) loaded in an 20 gauge pre-waxed brachytherapy needle. FDA UDIQty 2 - 0.50mm x 0.5cm Gold VISICOILS 15mm spacer 20g x 20cm Needle 2 - 0.50mm x 0.5cm VISICOIL separated by a 15mm spacer (Non-Stranded) loaded in an 20 gauge pre-waxed brachytherapy needle. FDA UDI
- Model / Reference
- TL-050-21520 FDA UDI
- Description
- 2 - 0.50mm x 0.5cm VISICOIL separated by a 15mm spacer (Non-Stranded) loaded in an 20 gauge pre-waxed brachytherapy needle. FDA UDIQty 2 - 0.50mm x 0.5cm Gold VISICOILS 15mm spacer 20g x 20cm Needle 2 - 0.50mm x 0.5cm VISICOIL separated by a 15mm spacer (Non-Stranded) loaded in an 20 gauge pre-waxed brachytherapy needle. FDA UDI
Identifiers
- Catalog Number
- TL-050-21520 FDA UDI
- Primary DI / UDI-DI
- EIBATL050215200 FDA UDIB887TL050215200 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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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 |
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Manufacturer
- Manufacturer
- Izi Medical Products Llc
Sources (2)
- FDA UDI ca9adeac-2ae4-463a-84a3-e04bdd57dc06 36 fields · synced Jun 8, 2026
- FDA UDI 6b3b465a-80e4-4b76-960b-e0a4f02f3ed8 36 fields · synced May 27, 2026