LOSPA&LOSPA IS Surgical Instruments

GUDID 08806373878022

T-HANDLE

Corentec Co., Ltd

Surgical instrument handle, non-torque-limiting
Primary Device ID08806373878022
NIH Device Record Key5fe10421-a4e2-47f0-91f5-697710bc6255
Commercial Distribution StatusIn Commercial Distribution
Brand NameLOSPA&LOSPA IS Surgical Instruments
Version Model NumberSI.ZH1.0002
Company DUNS688739895
Company NameCorentec Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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+82269374902
Emailra@corentec.com
Phone+82269374902
Emailra@corentec.com
Phone+82269374902
Emailra@corentec.com
Phone+82269374902
Emailra@corentec.com
Phone+82269374902
Emailra@corentec.com
Phone+82269374902
Emailra@corentec.com
Phone+82269374902
Emailra@corentec.com
Phone+82269374902
Emailra@corentec.com
Phone+82269374902
Emailra@corentec.com
Phone+82269374902
Emailra@corentec.com
Phone+82269374902
Emailra@corentec.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108806373878022 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806373878022]

Moist Heat or Steam Sterilization


[08806373878022]

Moist Heat or Steam Sterilization


[08806373878022]

Moist Heat or Steam Sterilization


[08806373878022]

Moist Heat or Steam Sterilization


[08806373878022]

Moist Heat or Steam Sterilization


[08806373878022]

Moist Heat or Steam Sterilization


[08806373878022]

Moist Heat or Steam Sterilization


[08806373878022]

Moist Heat or Steam Sterilization


[08806373878022]

Moist Heat or Steam Sterilization


[08806373878022]

Moist Heat or Steam Sterilization


[08806373878022]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-02
Device Publish Date2025-11-24

Devices Manufactured by Corentec Co., Ltd

08806373886850 - BENCOX Surgical Instruments2025-12-18 Rasp Handle
08806373888212 - BENCOX Surgical Instruments2025-12-18 BENCOX Cup 42-54mm Template (Delta) 105%
08806373888229 - BENCOX Surgical Instruments2025-12-18 BENCOX Cup 56-68mm Template (Delta) 105%
08806373888250 - BENCOX Surgical Instruments2025-12-18 BENCOX Cup 42-54mm Template (Delta) 115%
08806373888267 - BENCOX Surgical Instruments2025-12-18 BENCOX Cup 56-68mm Template (Delta) 115%
08806373888298 - BENCOX Surgical Instruments2025-12-18 BENCOX Cup 42-54mm Template (Delta) 120%
08806373888304 - BENCOX Surgical Instruments2025-12-18 BENCOX Cup 56-68mm Template (Delta) 120%
08806373892004 - BENCOX Surgical Instruments2025-12-18 Canal Probe

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.