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


[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

Devices Manufactured by ENZTEC LIMITED

09421028110624 - Enztec Femoral Impactor - DJO2026-02-09 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028110631 - DJO Femoral Impactor Head2026-02-09 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028112536 - Enztec Classic OCI - Trinket 5/16-24 UNF-022026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028113540 - Enztec Classic OCI - Trinket 3/8-16 UNC-012026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028113557 - Enztec Classic OCI - Trinket 5/16-24 UNF-012026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028113571 - Enztec Classic OCI - Trinket 3/8-24 UNF-012026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421038410516 - ATTUNE FEMORAL IMPACTOR2026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421038410523 - ATTUNE FEMORAL IMPACTOR HEAD2026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure

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