OncoSeedTM 6711-01016

GUDID 00840682101202

MEDI-PHYSICS, INC.

Manual brachytherapy source, permanent implant
Primary Device ID00840682101202
NIH Device Record Key4329f0b1-f81d-45c8-af7d-f2c1449c6b20
Commercial Distribution StatusIn Commercial Distribution
Brand NameOncoSeedTM
Version Model Number6711 - Iodine I-125 Seed 1.016 mCi
Catalog Number6711-01016
Company DUNS059470927
Company NameMEDI-PHYSICS, INC.
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 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)228-0126
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682101202 [Primary]

FDA Product Code

KXKSource, brachytherapy, radionuclide

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840682101202]

Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-09-24

On-Brand Devices [OncoSeedTM]

008406821022166711 - Iodine I-125 Seed 31.3 mCi
008406821021936711 - Iodine I-125 Seed 15.04 mCi
008406821021486711 - Iodine I-125 Seed 20.80 mCi
008406821021246711 - Iodine I-125 Seed 0.487 mCi
008406821021006711 - Iodine I-125 Seed 47.2 mCi
008406821020636711 - Iodine I-125 Seed 0.796 mCi
008406821020496711 - Iodine I-125 Seed 12.77 mCi
008406821019816711 - Iodine I-125 Seed 0.199 mCi
008406821019126711 - Iodine I-125 Seed 0.324 mCi
008406821019056711 - Iodine I-125 Seed 60.2 mCi
008406821018996711 - Iodine I-125 Seed 3.75 mCi
008406821018826711 - Iodine I-125 Seed 28.9 mCi
008406821018516711 - Iodine I-125 Seed 0.863 mCi
008406821018376711 - Iodine I-125 Seed 1.298 mCi
008406821018136711 - Iodine I-125 Seed 13.86 mCi
008406821017836711 - Iodine I-125 Seed 43.5 mCi
008406821017766711 - Iodine I-125 Seed 70.9 mCi
008406821017696711 - Iodine I-125 Seed 2.49 mCi
008406821017526711 - Iodine I-125 Seed 0.733 mCi
008406821017386711 - Iodine I-125 Seed 4.42 mCi
008406821017146711 - Iodine I-125 Seed 3.19 mCi
008406821017076711 - Iodine I-125 Seed 8.49 mCi
008406821016396711 - Iodine I-125 Seed 0.529 mCi
008406821016156711 - Iodine I-125 Seed 1.103 mCi
008406821015786711 - Iodine I-125 Seed 3.46 mCi
008406821015546711 - Iodine I-125 Seed 26.6 mCi
008406821015096711 - Iodine I-125 Seed 0.215 mCi
008406821014936711 - Iodine I-125 Seed 1.953 mCi
008406821014866711 - Iodine I-125 Seed 1.409 mCi
008406821014796711 - Iodine I-125 Seed 0.676 mCi
008406821014486711 - Iodine I-125 Seed 65.4 mCi
008406821014316711 - Iodine I-125 Seed 4.79 mCi
008406821013946711 - Iodine I-125 Seed 1.197 mCi
008406821013706711 - Iodine I-125 Seed 1.659 mCi
008406821013636711 - Iodine I-125 Seed 10.85 mCi
008406821013326711 - Iodine I-125 Seed 11.77 mCi
008406821013256711 - Iodine I-125 Seed 9.21 mCi
008406821012956711 - Iodine I-125 Seed 1.529 mCi
008406821012336711 - Iodine I-125 Seed 36.9 mCi
008406821012266711 - Iodine I-125 Seed 16.31 mCi
008406821012196711 - Iodine I-125 Seed 0.352 mCi
008406821012026711 - Iodine I-125 Seed 1.016 mCi
008406821011656711 - Iodine I-125 Seed 5.20 mCi
008406821011416711 - Iodine I-125 Seed 40.0 mCi
008406821011346711 - Iodine I-125 Seed 22.60 mCi
008406821011106711 - Iodine I-125 Seed 24.50 mCi
008406821010806711 - Iodine I-125 Seed 2.30 mCi
008406821010426711 - Iodine I-125 Seed 0.414 mCi
008406821010356711 - Iodine I-125 Seed 0.449 mCi
008406821010046711 - Iodine I-125 Seed 6.12 mCi
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.