Theragenics

FDA UDI

Class I (US FDA UDI)

by Theragenics Corp.

Identity

Trade Name: Theragenics FDA UDI
Generic Name: Brachytherapy injection needle FDA UDI
Device Name: 18ga x 20cm Brachytherapy Applicator Needle, Yellow FDA UDI
Model / Reference: CPPS-MN-1821-5 FDA UDI
Description: 18ga x 20cm Brachytherapy Applicator Needle, Yellow FDA UDI

Identifiers

Primary DI / UDI-DI: 00813787021751 FDA UDI
510(k) Number: K974118 FDA UDI
FDA Product Code: IWJ FDA UDI
GMDN Term: Brachytherapy injection needle FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.5650 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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 injection needle

Theragenics by Theragenics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K974118 also covers:

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 I	Pending data

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Manufacturer

Manufacturer: Theragenics Corp.

Sources (1)

FDA UDI 9965efed-d22a-4e68-b176-2676f8adbfd8 34 fields · synced May 30, 2026