I-125 SeedsTM in Carrier 6720-00215

GUDID 00840682100601

MEDI-PHYSICS, INC.

Manual brachytherapy source, permanent implant
Primary Device ID00840682100601
NIH Device Record Keyd0832254-4daf-42f0-b0f7-9169a8998ee2
Commercial Distribution StatusIn Commercial Distribution
Brand NameI-125 SeedsTM in Carrier
Version Model Number6720 - I-125 Seeds 0.215 mCi
Catalog Number6720-00215
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
GS100840682100601 [Primary]

FDA Product Code

KXKSource, brachytherapy, radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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 [I-125 SeedsTM in Carrier]

008406821022236720- I-125 Seeds 0.352 mCi
008406821021316720- I-125 Seeds 0.382 mCi
008406821020256720 - I-125 Seeds 0.254 mCi
008406821019506720 - I-125 Seeds 0.796 mCi
008406821019366720 - I-125 Seeds 0.275 mCi
008406821016916720 - I-125 Seeds 0.234 mCi
008406821015856720 - I-125 Seeds 0.623 mCi
008406821015166720 - I-125 Seeds 0.414 mCi
008406821014626720 - I-125 Seeds 0.574 mCi
008406821014556720 - I-125 Seeds 0.676 mCi
008406821014006720 - I-125 Seeds 0.199mCi
008406821013566720 - I-125 Seeds 0.299 mCi
008406821012886720 - I-125 Seeds 0.324 mCi
008406821010666720 - I-125 Seeds 0.529 mCi
008406821010116720- I-125 Seeds 0.487 mCi
008406821008096720 - I-125 Seeds 0.449 mCi
008406821007246720 - I-125 Seeds 1.016 mCi
008406821006186720 - I-125 Seeds 0.733 mCi
008406821006016720 - I-125 Seeds 0.215 mCi
008406821005576720- I-125 Seeds 0.937 mCi
008406821005406720 - I-125 Seeds 0.863 mCi

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