Identity
- Trade Name
- SPACER FDA UDI
- Generic Name
- Brachytherapy source spacer FDA UDI
- Device Name
- BRACHYTHERAPY FDA UDI
- Model / Reference
- IAS 910.5.0-50 FDA UDI
- Description
- BRACHYTHERAPY FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812444024432 FDA UDI
- 510(k) Number
- K103449 FDA UDI
- FDA Product Code
- KXK FDA UDI
- GMDN Term
- Brachytherapy source spacer 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
Category: Brachytherapy source spacer
Spacer by Riverpoint Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Brachytherapy source spacer.
- SourceLink™ — BARD BRACHYTHERAPY, INC · Class II
- BrachySource™, SourceCap™ — BARD BRACHYTHERAPY, INC · Class II
- Theragenics — THERAGENICS CORP. · Class II
- QuickLink™, SourceLink™ — BARD BRACHYTHERAPY, INC · Class II
- TheraSeed®, SourceLink™ — BARD BRACHYTHERAPY, INC · Class II
- Marker Seed - Preloaded in PSS1820SL3 Round Hub Needles, 3pk — Eckert & Ziegler BEBIG GmbH · Class I
- BrachySource™ — BARD BRACHYTHERAPY, INC · Class II
- TheraSeed®, SourceLink™ — BARD BRACHYTHERAPY, INC · Class II
Cleared under the same submission
K103449 also covers:
- BRACHYTHERAPY — RIVERPOINT MEDICAL LLC
- BRACHYTHERAPY — RIVERPOINT MEDICAL LLC
- BRACHYTHERAPY NEEDLE — RIVERPOINT MEDICAL LLC
- Brachytherapy — RIVERPOINT MEDICAL LLC
- Brachytherapy Needle — RIVERPOINT MEDICAL LLC
- Eckert & Ziegler — RIVERPOINT MEDICAL LLC
- FIDUCIAL NEEDLES — RIVERPOINT MEDICAL LLC
- FIDUCIAL NEEDLES — RIVERPOINT MEDICAL LLC
- FIDUCIAL NEEDLES — RIVERPOINT MEDICAL LLC
- GOLD FIDUCIAL MARKER — RIVERPOINT MEDICAL LLC
- GOLD FIDUCIAL MARKER — RIVERPOINT MEDICAL LLC
- GOLD FIDUCIAL MARKER — RIVERPOINT 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Riverpoint Medical Llc
Sources (1)
- FDA UDI 53eef31b-553f-4deb-9b14-08192bb1bbf8 34 fields · synced May 30, 2026