Identity
- Trade Name
- PL-8 FDA UDI
- Generic Name
- Prostate brachytherapy system applicator, manual FDA UDI
- Device Name
- Cesium-131 Implant Devices combined with MRI Markers will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. The PL-8 device is preloaded strands with Markers in 18G needles. FDA UDI
- Model / Reference
- PL-8 FDA UDI
- Description
- Cesium-131 Implant Devices combined with MRI Markers will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. The PL-8 device is preloaded strands with Markers in 18G needles. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860011485469 FDA UDI
- 510(k) Number
- K202267 FDA UDI
- FDA Product Code
- KXK FDA UDI
- GMDN Term
- Prostate brachytherapy system applicator, manual 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Prostate brachytherapy system applicator, manual
Pl-8 by GT Medical Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Prostate brachytherapy system applicator, manual.
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- Cradle — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Micro-Touch® Stabilizer LP — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Multi-Purpose Workstation™ Stepper — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Small Prostate Brachytherapy Kit — LIBERTY MEDICAL INC · Class I
Cleared under the same submission
K202267 also covers:
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
- GT Medical Technologies
Sources (1)
- FDA UDI d0df2dd4-174a-46a5-bb11-945b52e0ee5a 34 fields · synced Sep 18, 2026