Enztec Classic OCI - Corin Trinket 3991055001

GUDID 09421028111317

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

ENZTEC LIMITED

Orthopaedic implant impactor, reusable
Primary Device ID09421028111317
NIH Device Record Key7719a620-0386-48d2-b1f1-04170009b815
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnztec Classic OCI - Corin Trinket
Version Model Number3991055001
Catalog Number3991055001
Company DUNS592616445
Company NameENZTEC LIMITED
Device Count1
DM Exempttrue
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
GS109421028111317 [Primary]

FDA Product Code

HWAImpactor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


[09421028111317]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-14
Device Publish Date2026-01-06

Devices Manufactured by ENZTEC LIMITED

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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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