FDA.reportPublic FDA data

Enztec Straight Broach Holder

Primary DI
09421028118125
Brand
Enztec Straight Broach Holder
Company
ENZTEC LIMITED
Model
1124.00.000
Catalog number
1124.00.000
Device description
A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
Published
2023-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421028118125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421028118125094210281181259421028118125

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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
09421028110853Tensioner, AP Sizer2120.00.0002120.00.0002026-07-30
09421028110877Tensioner, Balancer2118.00.0002118.00.0002026-07-30
09421028110884Tensioner, Distractor2119.00.0002119.00.0002026-07-30
09421038412237KA Femoral Alignment Guide293-777293-7772026-06-24
09421038412244KA Femoral Alignment Guide - Medial Paddle293-778293-7782026-06-24
09421038412251KA Femoral Alignment Guide - Lateral Paddle293-779293-7792026-06-24
09421038412268KA Femoral Alignment Guide - Fan293-780293-7802026-06-24
09421038412275KA Femoral Alignment Guide – IM Guide293-781293-7812026-06-24
09421038412282KA Femoral Alignment Guide – Pin Guide Connector293-782293-7822026-06-24
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

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