BENCOX THR System

GUDID 08800068957030

Bencox Mirabo PE Liner Trial 32D-ELV15-PPX

Corentec Co., Ltd

Surgical implant/trial-implant/sizer holder, reusable
Primary Device ID08800068957030
NIH Device Record Key6412372d-5f86-45c7-bdd4-0c7b8bc9e284
Commercial Distribution StatusIn Commercial Distribution
Brand NameBENCOX THR System
Version Model NumberHA.01L.3244
Company DUNS688739895
Company NameCorentec Co., Ltd
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82415857114
Emailsungwon.yang@corentec.com
Phone+82415857114
Emailsungwon.yang@corentec.com
Phone+82415857114
Emailsungwon.yang@corentec.com
Phone+82415857114
Emailsungwon.yang@corentec.com
Phone+82415857114
Emailsungwon.yang@corentec.com
Phone+82415857114
Emailsungwon.yang@corentec.com
Phone+82415857114
Emailsungwon.yang@corentec.com
Phone+82415857114
Emailsungwon.yang@corentec.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108800068957030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800068957030]

Moist Heat or Steam Sterilization

[08800068957030]

Moist Heat or Steam Sterilization

[08800068957030]

Moist Heat or Steam Sterilization

[08800068957030]

Moist Heat or Steam Sterilization

[08800068957030]

Moist Heat or Steam Sterilization

[08800068957030]

Moist Heat or Steam Sterilization

[08800068957030]

Moist Heat or Steam Sterilization

[08800068957030]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-28
Device Publish Date2021-07-20

On-Brand Devices [BENCOX THR System]

08800068958648Shell Trial 56mm(D) (BENCOX MIRABO CUP)
08800068958631Bipolar Cup Trial Ring 28mm-PPX
08800068958624Bipolar Cup Trial 41mm-PPX
08800068958617Bencox Mirabo PE Liner Trial 36C+-ELV15-PPX
08800068958600Bencox Mirabo PE Liner Trial 32C+-ELV15-PPX
08800068958594Bencox Mirabo PE Liner Trial 28F-ELV15-PPX
08800068958587Bencox Mirabo PE Liner Trial 28C+-ELV15-PPX
08800068958570Impacting Part 40mm-PPX
08800068958563Impacting Part 36mm-PPX
08800068958556Impacting Part 32mm-PPX
08800068958549Impacting Part 28mm-PPX
08800068958525Bipolar Cup Trial Ring 22mm-PPX
08800068958518Bipolar Cup Trial 60mm-PPX
08800068958501Bipolar Cup Trial 59mm-PPX
08800068958495Bipolar Cup Trial 58mm-PPX
08800068958488Bipolar Cup Trial 57mm-PPX
08800068958471Bipolar Cup Trial 56mm-PPX
08800068958464Bipolar Cup Trial 55mm-PPX
08800068958457Bipolar Cup Trial 54mm-PPX
08800068958440Bipolar Cup Trial 53mm-PPX
08800068958433Bipolar Cup Trial 52mm-PPX
08800068958426Bipolar Cup Trial 51mm-PPX
08800068958419Bipolar Cup Trial 50mm-PPX
08800068958402Bipolar Cup Trial 49mm-PPX
08800068958396Bipolar Cup Trial 48mm-PPX
08800068958389Bipolar Cup Trial 47mm-PPX
08800068958372Bipolar Cup Trial 46mm-PPX
08800068958365Bipolar Cup Trial 45mm-PPX
08800068958358Bipolar Cup Trial 44mm-PPX
08800068958341Bipolar Cup Trial 43mm-PPX
08800068958334Bipolar Cup Trial 42mm-PPX
08800068958327Bipolar Cup Trial 40mm-PPX
08800068958310Bipolar Cup Trial 39mm-PPX
08800068958303Bipolar Cup Trial 38mm-PPX
08800068958280Head Trial 40XL+8mm Offset-PPX
08800068958273Head Trial 40XXL-PPX
08800068958266Head Trial 40XL-PPX
08800068958259Head Trial 40L-PPX
08800068958242Head Trial 40S-PPX
08800068958235Head Trial 36XL+8mm Offset-PPX
08800068958228Head Trial 36XXL-PPX
08800068958211Head Trial 36XL-PPX
08800068958204Head Trial 36L-PPX
08800068958198Head Trial 36M-PPX
08800068958181Head Trial 36S-PPX
08800068958174Head Trial 32XXL-PPX
08800068958167Head Trial 32XL-PPX
08800068958150Head Trial 32L-PPX
08800068958143Head Trial 32M-PPX
08800068958136Head Trial 32S-PPX
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.