Enztec Premium Patella Saw Guide – 9mm (1.37mm Blade) 4240-4409

GUDID 09421028118736

A reusable surgical instrument intended to be used during an orthopaedic surgical procedure

ENZTEC LIMITED

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID09421028118736
NIH Device Record Keyb9c34dd4-c104-4b55-9746-cfdccdb9ba7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnztec Premium Patella Saw Guide – 9mm (1.37mm Blade)
Version Model Number4240-4409
Catalog Number4240-4409
Company DUNS592616445
Company NameENZTEC LIMITED
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109421028118736 [Primary]

FDA Product Code

FZXGuide, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421028118736]

Moist Heat or Steam Sterilization


[09421028118736]

Moist Heat or Steam Sterilization


[09421028118736]

Moist Heat or Steam Sterilization


[09421028118736]

Moist Heat or Steam Sterilization


[09421028118736]

Moist Heat or Steam Sterilization


[09421028118736]

Moist Heat or Steam Sterilization


[09421028118736]

Moist Heat or Steam Sterilization


[09421028118736]

Moist Heat or Steam Sterilization


[09421028118736]

Moist Heat or Steam Sterilization


[09421028118736]

Moist Heat or Steam Sterilization


[09421028118736]

Moist Heat or Steam Sterilization


[09421028118736]

Moist Heat or Steam Sterilization


[09421028118736]

Moist Heat or Steam Sterilization


[09421028118736]

Moist Heat or Steam Sterilization


[09421028118736]

Moist Heat or Steam Sterilization


[09421028118736]

Moist Heat or Steam Sterilization


[09421028118736]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-01
Device Publish Date2023-10-24

Devices Manufactured by ENZTEC LIMITED

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09421028118705 - MODULAR BROACH HANDLE, DUAL OFFSET, RIGHT2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028118712 - MODULAR BROACH HANDLE, DUAL OFFSET, LEFT2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119030 - Adjustable Cutting Block – 1.27mm2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119085 - MODULAR BROACH HANDLE, GRIP2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119092 - MODULAR BROACH HANDLE, STRIKE PLATE2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure

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