OptionELITE Vena Cava Filter, 100cm 352506100E

GUDID 00857141005018

Rex Medical LLP

Vena cava filter, temporary/permanent
Primary Device ID00857141005018
NIH Device Record Key056d13f6-f7b8-4ea7-9b82-88fb36dca324
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptionELITE Vena Cava Filter, 100cm
Version Model Number352506100E
Catalog Number352506100E
Company DUNS079535216
Company NameRex Medical LLP
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
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

Customer Support Contacts

Phone800-927-4669
EmailCustomer.Service@argonmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100857141005018 [Primary]

FDA Product Code

DTKFilter, Intravascular, Cardiovascular

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 Date2015-12-07

Devices Manufactured by Rex Medical LLP

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00857141005278 - Quadra-Fuse Multi-Pronged Injection Needle2020-12-15
00857141005285 - Quadra-Fuse Multi-Pronged Injection Needle2020-12-15
00857141005292 - Quadra-Fuse Multi-Pronged Injection Needle2020-12-15
00857141005308 - Quadra-Fuse Multi-Pronged Injection Needle2020-12-15
00857141005315 - Quadra-Fuse Multi-Pronged Injection Needle2020-12-15
00857141005001 - OptionELITE Vena Cava Filter2018-03-29
00857141005018 - OptionELITE Vena Cava Filter, 100cm2018-03-29
00857141005018 - OptionELITE Vena Cava Filter, 100cm2018-03-29

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