SeedLock

GUDID 00813787021294

Prostate Seeding Ndl 1pk Pink EZ (NO PLUG)

THERAGENICS CORPORATION

Brachytherapy needle
Primary Device ID00813787021294
NIH Device Record Key2beb5f94-60bf-45f7-83a5-93d12498d1b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSeedLock
Version Model NumberPSS1820EZ-1
Company DUNS114379522
Company NameTHERAGENICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100813787021294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IWJSystem, Applicator, Radionuclide, Manual

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00813787021294]

Ethylene Oxide


[00813787021294]

Ethylene Oxide


[00813787021294]

Ethylene Oxide


[00813787021294]

Ethylene Oxide


[00813787021294]

Ethylene Oxide


[00813787021294]

Ethylene Oxide


[00813787021294]

Ethylene Oxide


[00813787021294]

Ethylene Oxide


[00813787021294]

Ethylene Oxide


[00813787021294]

Ethylene Oxide


[00813787021294]

Ethylene Oxide


[00813787021294]

Ethylene Oxide


[00813787021294]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-04

On-Brand Devices [SeedLock]

00813787021294Prostate Seeding Ndl 1pk Pink EZ (NO PLUG)
00813787021287Prostate Seeding Needle "SeedLock Pre-Plugged", 1-pack
00813787021270Prostate Seeding Needle "SeedLock Pre-Plugged", 5-pack
00813787021263Prostate Seeding Needle "SeedLock Pre-Plugged", Box 50

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