Theragenics

FDA UDI

Class II (US FDA UDI)

by Theragenics Corp.

Identity

Trade Name: Theragenics FDA UDI
Generic Name: Brachytherapy source spacer FDA UDI
Device Name: Bio Spacer 910 5.0mm, Nonsterile, QTY 50 FDA UDI
Model / Reference: PSS-910-50-50NS FDA UDI
Description: Bio Spacer 910 5.0mm, Nonsterile, QTY 50 FDA UDI

Identifiers

Primary DI / UDI-DI: 00813787021669 FDA UDI
510(k) Number: K013964 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Brachytherapy source spacer

Theragenics by Theragenics Corp. — 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
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
QuickLink™, BrachySource™ — BARD BRACHYTHERAPY, INC · Class II

Cleared under the same submission

K013964 also covers:

Theragenics — 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 357a9602-1239-4402-926b-a19bf7b09623 34 fields · synced May 30, 2026