BENCOX Total Hip System

GUDID 08800068904683

BENCOX Mirabo Z cup Cortinium-3hole, D50

Corentec Co., Ltd

Metallic acetabulum prosthesis
Primary Device ID08800068904683
NIH Device Record Keyfc0a9334-66d1-4173-9a6b-e6dd296ad3c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBENCOX Total Hip System
Version Model NumberH1.A23.2050
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 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

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
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
Phone+82415857114
Emailsungwon.yang@corentec.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108800068904683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-15
Device Publish Date2023-03-07

On-Brand Devices [BENCOX Total Hip System]

08806373854095BENCOX Mirabo Z cup Cortinium - 3hole, D68
08806373854088BENCOX Mirabo Z cup Cortinium - 3hole, D66
08806373854071BENCOX Mirabo Z cup Cortinium - 3hole, D64
08806373854064BENCOX Mirabo Z cup Cortinium - 3hole, D62
08806373854057BENCOX Mirabo Z cup Cortinium - 3hole, D60
08806373854040BENCOX Mirabo Z cup Cortinium - 3hole, D58
08806373854033BENCOX Mirabo Z cup Cortinium - 3hole, D56
08806373854026BENCOX Mirabo Z cup Cortinium - 3hole, D54
08806373854019BENCOX Mirabo Z cup Cortinium - 3hole, D52
08806373854002BENCOX Mirabo Z cup Cortinium - 3hole, D50
08806373853999BENCOX Mirabo Z cup Cortinium - 3hole, D48
08806373853982BENCOX Mirabo Z Cup Cortinium - 3hole, D46
08800068901545BENCOX Mirabo PE Liner - Elevated type 10° 36/42mm
08800068901538BENCOX Mirabo PE Liner - Elevated type 10° 32/42mm
08800068901521BENCOX Mirabo PE Liner - Elevated type 10° 28/42mm
08800068901514BENCOX Mirabo PE Liner -Elevated type 15° 36/42mm
08800068901507BENCOX Mirabo PE Liner - Elevated type 15° 28/42mm
08800068901491BENCOX Mirabo PE Liner - Standard 36/42mm
08800068901484BENCOX Mirabo PE Liner - Standard 32/42mm
08800068901477BENCOX Mirabo PE Liner - Standard 28/42mm
08800068901460BENCOX Mirabo PE Liner- Elevated type 15° 32/42mm
08800068901170BENCOX Mirabo cup - Multi-hole, D50/42
08800068901163BENCOX Mirabo cup - 3hole, D50/42
08800068904317BENCOX Mirabo Z cup Cortinium - 3hole, D72
08800068904300BENCOX Mirabo Z cup Cortinium - 3hole, D70
08800068901392BENCOX Mirabo Z cup Cortinium - 3hole, D44
08800068901385BENCOX Mirabo Z cup Cortinium - 3hole, D74
08800068904676BENCOX Mirabo Z cup Cortinium - 3hole, D56
08800068904683BENCOX Mirabo Z cup Cortinium-3hole, D50
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