Identity
- Trade Name
- RAPID StrandTM Rx FDA UDI
- Generic Name
- Manual brachytherapy source, permanent implant FDA UDI
- Model / Reference
- I125 RSRx Braided Square Needle FDA UDI
Identifiers
- Catalog Number
- I125RSRX-SQR FDA UDI
- Primary DI / UDI-DI
- 00840682102179 FDA UDI
- FDA Product Code
- KXK FDA UDI
- GMDN Term
- Manual brachytherapy source, permanent implant 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Manual brachytherapy source, permanent implant
RAPID StrandTM Rx by Medi-Physics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual brachytherapy source, permanent implant.
- TheraSeed — THERAGENICS CORP. · Class II
- TheraSeed® — BARD BRACHYTHERAPY, INC · Class II
- TheraSphere Y90 Glass Microspheres 16.0 GBq (US Commercial) — BIOCOMPATIBLES UK LTD · Class III
- Gold Marker — RIVERPOINT MEDICAL LLC · Class II
- BrachySource™ — BARD BRACHYTHERAPY, INC · Class II
- TheraSeed — THERAGENICS CORP. · Class II
- I-Seed Agx100 — THERAGENICS CORP. · Class II
- TheraSphere Y90 Glass Microspheres 17.5 GBq (US Commercial) — BIOCOMPATIBLES UK LTD · Class III
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
- Medi-Physics, Inc.
Sources (1)
- FDA UDI 07e09ed6-6d47-44ea-8d28-e17fc69b039a 34 fields · synced May 30, 2026