Model 200 TheraSeed® Palladium-103 Loose Seed TS200L

GUDID 00801741078385

PD103 Loose Seeds, Non-Sterile

Bard Brachytherapy, Inc.

Manual brachytherapy source, permanent implant
Primary Device ID00801741078385
NIH Device Record Keyf03e602e-c9cb-446e-bbfb-ecba22fd578a
Commercial Distribution StatusIn Commercial Distribution
Brand NameModel 200 TheraSeed® Palladium-103 Loose Seed
Version Model NumberTS200L
Catalog NumberTS200L
Company DUNS185524860
Company NameBard Brachytherapy, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741078385 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KXKSource, brachytherapy, radionuclide

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00801741078385]

Moist Heat or Steam Sterilization;Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-05

On-Brand Devices [Model 200 TheraSeed® Palladium-103 Loose Seed]

00801741078484PD103 Loose Seeds, Sterile, Calibrated
00801741078477PD103 Loose Seeds, Non-Sterile, Calibrated
00801741078392PD103 Loose Seeds, Sterile
00801741078385PD103 Loose Seeds, Non-Sterile

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.