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TheraStrand® with I-Seed

FDA UDI

Class II (US FDA UDI)

by Theragenics Corp.

Identity

Trade Name
TheraStrand® with I-Seed FDA UDI
Generic Name
Manual brachytherapy source, permanent implant FDA UDI
Device Name
Loose TheraStrand® with 1-6 seeds, standard spacing for CN FDA UDI
Model / Reference
XX72xiL FDA UDI
Description
Loose TheraStrand® with 1-6 seeds, standard spacing for CN FDA UDI

Identifiers

Primary DI / UDI-DI
00813787020440 FDA UDI
510(k) Number
K043596 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
Not 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

TheraStrand® with I-Seed by Theragenics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K043596 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Theragenics Corp.

Sources (1)

  • FDA UDI e6e52986-a614-41f9-92dc-9ac418871703 35 fields · synced Jun 8, 2026