FDA.reportPublic FDA data

DXTEND HUM BROACH DIA 14 MM

Primary DI
09421038410899
Brand
DXTEND HUM BROACH DIA 14 MM
Company
ENZTEC LIMITED
Model
2307-89-014
Catalog number
2307-89-014
Device description
A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
Published
2025-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTRRasp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421038410899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421038410899094210384108999421038410899

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
592616445
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421038413159Reamer, Acetabular, 36mm Full5900-RF365900-RF362026-04-16
09421038413166Reamer, Acetabular, 37mm Full5900-RF375900-RF372026-04-16
09421038413173Reamer, Acetabular, 38mm Full5900-RF385900-RF382026-04-16
09421038413180Reamer, Acetabular, 39mm Full5900-RF395900-RF392026-04-16
09421038413197Reamer, Acetabular, 40mm Full5900-RF405900-RF402026-04-16
09421038413203Reamer, Acetabular, 41mm Full5900-RF415900-RF412026-04-16
09421038413210Reamer, Acetabular, 42mm Full5900-RF425900-RF422026-04-16
09421038413227Reamer, Acetabular, 43mm Full5900-RF435900-RF432026-04-16
09421038413234Reamer, Acetabular, 44mm Full5900-RF445900-RF442026-04-16
09421038413241Reamer, Acetabular, 45mm Full5900-RF455900-RF452026-04-16
09421038413258Reamer, Acetabular, 46mm Full5900-RF465900-RF462026-04-16
09421038413265Reamer, Acetabular, 47mm Full5900-RF475900-RF472026-04-16
09421038413272Reamer, Acetabular, 48mm Full5900-RF485900-RF482026-04-16
09421038413289Reamer, Acetabular, 49mm Full5900-RF495900-RF492026-04-16
09421038413296Reamer, Acetabular, 50mm Full5900-RF505900-RF502026-04-16
09421038413302Reamer, Acetabular, 51mm Full5900-RF515900-RF512026-04-16
09421038413319Reamer, Acetabular, 52mm Full5900-RF525900-RF522026-04-16
09421038413326Reamer, Acetabular, 53mm Full5900-RF535900-RF532026-04-16
09421038413333Reamer, Acetabular, 54mm Full5900-RF545900-RF542026-04-16
09421038413340Reamer, Acetabular, 55mm Full5900-RF555900-RF552026-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806395408917PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408924PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408931PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408948PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408955PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408962PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408979PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408986PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408993PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395409006PulsarGS Medical Co., Ltd.HTR2022-11-01
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00841732124684GENERIC Surgical InstrumentsCTL Medical CorporationHTR2019-10-18
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10381780393016Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-05-02
10381780280859Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.HTR2018-04-13
10381780280866Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.HTR2018-04-13
10381780467076Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-09
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10381780192862Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-02
10381780193012Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-02
10381780461616Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-03-22
10381780212188Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-03-01