I-125 SeedTM Sterile Convenience Pack

FDA UDI

Class II (US FDA UDI)

by Medi-Physics, Inc.

Identity

Trade Name: I-125 SeedTM Sterile Convenience Pack FDA UDI
Generic Name: Manual brachytherapy source, permanent implant FDA UDI
Model / Reference: 6715 - I-125 Seed 0.352mCi FDA UDI

Identifiers

Catalog Number: 6715-00352 FDA UDI
Primary DI / UDI-DI: 00840682101264 FDA UDI
FDA Product Code: IWG 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Manual brachytherapy source, permanent implant

I-125 SeedTM Sterile Convenience Pack 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.

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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

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Manufacturer

Manufacturer: Medi-Physics, Inc.

Sources (1)

FDA UDI 19529212-3350-4998-b122-01d288e965e5 34 fields · synced Jun 8, 2026