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Model 200 TheraSeed® Palladium-103 Device in Isosleeve™ Delivery System

FDA UDI

Class II (US FDA UDI)

by Bard Brachytherapy, Inc

Identity

Trade Name
Model 200 TheraSeed® Palladium-103 Device in Isosleeve™ Delivery System FDA UDI
Generic Name
Manual brachytherapy source, permanent implant FDA UDI
Device Name
Model 200 TheraSeed® Palladium-103 Seeds IN ISOSLEEVE, STRL FDA UDI
Model / Reference
IS200 FDA UDI
Description
Model 200 TheraSeed® Palladium-103 Seeds IN ISOSLEEVE, STRL FDA UDI

Identifiers

Catalog Number
IS200 FDA UDI
Primary DI / UDI-DI
00801741078514 FDA UDI
510(k) Number
K060636 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Model 200 TheraSeed® Palladium-103 Device in Isosleeve™ Delivery System by Bard Brachytherapy, Inc — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K060636 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bard Brachytherapy, Inc

Sources (1)

  • FDA UDI 2976e508-c14b-470c-a1b8-134899913913 37 fields · synced May 30, 2026