Identity
- Trade Name
- I-Seed Agx100 FDA UDI
- Generic Name
- Manual brachytherapy source, permanent implant FDA UDI
- Device Name
- High activity loose seeds for the Eye FDA UDI
- Model / Reference
- XX307i FDA UDI
- Description
- High activity loose seeds for the Eye FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813787020051 FDA UDI
- 510(k) Number
- K103319 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
No
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
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Manual brachytherapy source, permanent implant
I-Seed Agx100 by Theragenics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual brachytherapy source, permanent implant.
- OncoSeedTM — MEDI-PHYSICS, INC. · Class II
- TheraSeed® — BARD BRACHYTHERAPY, INC · Class II
- I-125 SeedTM Sterile Convenience Pack — MEDI-PHYSICS, INC. · Class II
- TheraSphere Y90 Glass Microspheres 16.0 GBq (US Commercial) — BIOCOMPATIBLES UK LTD · Class III
- Gold Marker — RIVERPOINT MEDICAL LLC · Class II
- Thin SeedTM — MEDI-PHYSICS, INC. · Class II
- OncoSeedTM — MEDI-PHYSICS, INC. · Class II
- BrachySource™ — BARD BRACHYTHERAPY, INC · Class II
Cleared under the same submission
K103319 also covers:
- I-Seed Agx100 — THERAGENICS CORP.
- I-Seed Agx100 — THERAGENICS CORP.
- I-Seed Agx100 — THERAGENICS CORP.
- I-Seed Agx100 — THERAGENICS CORP.
- I-Seed Agx100 — THERAGENICS CORP.
- I-Seed Agx100 — THERAGENICS CORP.
- I-Seed Agx100 — THERAGENICS CORP.
- I-Seed Agx100 — THERAGENICS CORP.
- I-Seed Agx100 — THERAGENICS CORP.
- I-Seed Agx100 — THERAGENICS CORP.
- I-Seed Agx100 — THERAGENICS CORP.
- I-Seed Agx100 — THERAGENICS CORP.
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
- Theragenics Corp.
Sources (1)
- FDA UDI 0199e361-0e2f-425b-be0d-3aa3a3752afa 34 fields · synced May 30, 2026