Identity
- Trade Name
- Stellar Medical FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- 3, 18 ga x 20 cm needles, each containing 1, 1.0 x 10.0 mm gold marker, St FDA UDI
- Model / Reference
- 10103SM FDA UDI
- Description
- 3, 18 ga x 20 cm needles, each containing 1, 1.0 x 10.0 mm gold marker, St FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853162006126 FDA UDI
- 510(k) Number
- K092041 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Radiological image marker, implantableBrachytherapy injection needle
Stellar Medical by Stellar Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Brachytherapy injection needle.
- Best Medical International — Best Medical International, Inc. · Class I
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- Advantage-Strand® and Advantage-Load® with Advantage I-125® — ISOAID, L.L.C. · Class II
- GOLD FIDUCIAL MARKER — RIVERPOINT MEDICAL LLC · Class II
- Best Medical International — Best Medical International, Inc. · Class II
- Best Medical International — Best Medical International, Inc. · Class II
- RIVERPOINT BRACHYTHERAPY — RIVERPOINT MEDICAL LLC · Class II
Cleared under the same submission
K092041 also covers:
- Stellar Medical — Stellar Medical, LLC
- Stellar Medical — Stellar Medical, LLC
- Stellar Medical — Stellar Medical, LLC
- Stellar Medical — Stellar Medical, LLC
- Stellar Medical — Stellar Medical, LLC
- Stellar Medical — Stellar Medical, LLC
- Stellar Medical — Stellar Medical, LLC
- Stellar Medical — Stellar Medical, LLC
- Stellar Medical — Stellar Medical, LLC
- Stellar Medical — Stellar Medical, LLC
- Stellar Medical — Stellar Medical, LLC
- Stellar Medical — Stellar Medical, 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
- Stellar Medical, LLC
Sources (1)
- FDA UDI f9e4c06e-fc7e-40bc-a5c4-635c6df5f1e1 34 fields · synced May 30, 2026