BENCOX Bipolar Cup System

GUDID 08806373869440

BENCOX Bipolar Cup 53mm-Insert

Corentec Co., Ltd

Metallic femoral head prosthesis
Primary Device ID08806373869440
NIH Device Record Keycebdd7da-3e4e-4f42-b273-d20b90b169ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameBENCOX Bipolar Cup System
Version Model NumberH2.A51.0053-01
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108806373869440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-17
Device Publish Date2020-04-09

On-Brand Devices [BENCOX Bipolar Cup System]

08806373869280BENCOX Bipolar Cup 60mm
08806373869273BENCOX Bipolar Cup 57mm
08806373869266BENCOX Bipolar Cup 56mm
08806373869259BENCOX Bipolar Cup 55mm
08806373869242BENCOX Bipolar Cup 54mm
08806373869235BENCOX Bipolar Cup 53mm
08806373869228BENCOX Bipolar Cup 52mm
08806373869211BENCOX Bipolar Cup 51mm
08806373869204BENCOX Bipolar Cup 50mm
08806373869198BENCOX Bipolar Cup 49mm
08806373869181BENCOX Bipolar Cup 48mm
08806373869174BENCOX Bipolar Cup 47mm
08806373869167BENCOX Bipolar Cup 46mm
08806373869150BENCOX Bipolar Cup 45mm
08806373869143BENCOX Bipolar Cup 44mm
08806373869136BENCOX Bipolar Cup 43mm
08806373869129BENCOX Bipolar Cup 42mm
08806373869112BENCOX Bipolar Cup 41mm
08806373869105BENCOX Bipolar Cup 40mm
08806373869099BENCOX Bipolar Cup 39mm
08806373869068BENCOX Bipolar Cup 38mm
08806373869518PE Ring 28mm
08806373869501PE Ring 22mm
08806373869495BENCOX Bipolar Cup 60mm-Insert
08806373869488BENCOX Bipolar Cup 57mm-Insert
08806373869471BENCOX Bipolar Cup 56mm-Insert
08806373869464BENCOX Bipolar Cup 55mm-Insert
08806373869457BENCOX Bipolar Cup 54mm-Insert
08806373869440BENCOX Bipolar Cup 53mm-Insert
08806373869433BENCOX Bipolar Cup 52mm-Insert
08806373869426BENCOX Bipolar Cup 51mm-Insert
08806373869419BENCOX Bipolar Cup 50mm-Insert
08806373869402BENCOX Bipolar Cup 49mm-Insert
08806373869396BENCOX Bipolar Cup 48mm-Insert
08806373869389BENCOX Bipolar Cup 47mm-Insert
08806373869372BENCOX Bipolar Cup 46mm-Insert
08806373869365BENCOX Bipolar Cup 45mm-Insert
08806373869358BENCOX Bipolar Cup 44mm-Insert
08806373869341BENCOX Bipolar Cup 43mm-Insert
08806373869327BENCOX Bipolar Cup 41mm-Insert
08806373869310BENCOX Bipolar Cup 40mm-Insert
08806373869303BENCOX Bipolar Cup 39mm-Insert
08806373869297BENCOX Bipolar Cup 38mm-Insert
08806373869334BENCOX Bipolar Cup 42mm-Insert

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