FDA.reportPublic FDA data

BENCOX DA Instruments Hip System

Primary DI
08800017285429
Brand
BENCOX DA Instruments Hip System
Company
Corentec Co., Ltd
Model
HA.0B2.0004
Device description
Anteversion Guide-Anterior Direction
Published
2024-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTHProtractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTHProtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800017285429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800017285429088000172854298800017285429

GMDN Terms#

Term, Definition table
TermDefinition
Bone-angle protractorA device intended to be used to measure the angles of bones, e.g., on x-rays or during surgery. It is commonly known as a protractor. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+820269374902ra@corentec.com

Regulatory Flags#

DUNS number
688739895
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800068946966BENCOXHA.018.28352026-07-01
08800068946973BENCOXHA.018.40622026-07-01
08800068963666BENCOXHA.018.36422026-07-01
08806373897344BENCOXHA.018.28372026-07-01
08806373897351BENCOXHA.018.32392026-07-01
08806373897368BENCOXHA.018.36442026-07-01
08806373897375BENCOXHA.018.36482026-07-01
08806373897382BENCOXHA.018.36522026-07-01
08809945870332BENCOX InstrumentHA.014.00042024-04-24
08800068983558BENCOXHA.0B8.00012026-07-24
08800017271095BENCOXHA.02G.00012026-04-10
08800017269726EXULT Knee Replacement SystemK3.FAL.73762020-05-21
08800017269733EXULT Knee Replacement SystemK3.FAR.73762020-05-21
08800017269740EXULT Knee Replacement SystemK3.FAL.76782020-05-21
08800017269757EXULT Knee Replacement SystemK3.FAR.76782020-05-21
08800017269764EXULT Knee Replacement SystemK3.FBL.73762020-05-21
08800017269771EXULT Knee Replacement SystemK3.FBR.73762020-05-21
08800017269788EXULT Knee Replacement SystemK3.FBL.76782020-05-21
08800017269795EXULT Knee Replacement SystemK3.FBR.76782020-05-21
08800017260853EXULT Knee Replacement SystemK3.BFN.36572020-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008411321863743P Hip SystemORTHOPEDIATRICS CORP.HTH2025-06-19
008411321863813P Hip SystemORTHOPEDIATRICS CORP.HTH2025-06-19
008411321863983P Hip SystemORTHOPEDIATRICS CORP.HTH2025-06-19
008411321874943P Hip SystemORTHOPEDIATRICS CORP.HTH2025-06-19
G223WRROGPRO0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHTH2022-12-05
00614950025503ACEACE SURGICAL SUPPLY CO., INC.HTH2019-10-24
00842430108891ScoliometerMIZUHO ORTHOPEDIC SYSTEMS, INC.HTH2019-04-02
00889024038004NAZimmer, Inc.HTH2016-07-27