TriVerse Locking Femoral Impactor Head 02-039-19-1301

GUDID 09421028118903

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

ENZTEC LIMITED

Orthopaedic implant impactor, reusable
Primary Device ID09421028118903
NIH Device Record Key3d4a1be3-5029-4b50-aa71-8a925d15588d
Commercial Distribution StatusIn Commercial Distribution
Brand NameTriVerse Locking Femoral Impactor Head
Version Model Number02-039-19-1301
Catalog Number02-039-19-1301
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
GS109421028118903 [Primary]

FDA Product Code

HWAImpactor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421028118903]

Moist Heat or Steam Sterilization


[09421028118903]

Moist Heat or Steam Sterilization


[09421028118903]

Moist Heat or Steam Sterilization


[09421028118903]

Moist Heat or Steam Sterilization


[09421028118903]

Moist Heat or Steam Sterilization


[09421028118903]

Moist Heat or Steam Sterilization


[09421028118903]

Moist Heat or Steam Sterilization


[09421028118903]

Moist Heat or Steam Sterilization


[09421028118903]

Moist Heat or Steam Sterilization


[09421028118903]

Moist Heat or Steam Sterilization


[09421028118903]

Moist Heat or Steam Sterilization


[09421028118903]

Moist Heat or Steam Sterilization


[09421028118903]

Moist Heat or Steam Sterilization


[09421028118903]

Moist Heat or Steam Sterilization


[09421028118903]

Moist Heat or Steam Sterilization


[09421028118903]

Moist Heat or Steam Sterilization


[09421028118903]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-25
Device Publish Date2023-12-15

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09421028119924 - Enztec Trinket M8x1.25-012024-09-02 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028115056 - Enztec Cup Impactor Alignment Guide - Supine2024-08-23 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028115063 - Enztec Cup Impactor Alignment Guide - Lateral2024-08-23 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure

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