Enztec Classic OCI - Tornier Trinket 3991077001

GUDID 09421028111362

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

ENZTEC LIMITED

Orthopaedic implant impactor, reusable
Primary Device ID09421028111362
NIH Device Record Keyb1007f47-6031-48a3-86cb-6170382614ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnztec Classic OCI - Tornier Trinket
Version Model Number3991077001
Catalog Number3991077001
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
GS109421028111362 [Primary]

FDA Product Code

HWAImpactor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421028111362]

Moist Heat or Steam Sterilization

[09421028111362]

Moist Heat or Steam Sterilization

[09421028111362]

Moist Heat or Steam Sterilization

[09421028111362]

Moist Heat or Steam Sterilization

[09421028111362]

Moist Heat or Steam Sterilization

[09421028111362]

Moist Heat or Steam Sterilization

[09421028111362]

Moist Heat or Steam Sterilization

[09421028111362]

Moist Heat or Steam Sterilization

[09421028111362]

Moist Heat or Steam Sterilization

[09421028111362]

Moist Heat or Steam Sterilization

[09421028111362]

Moist Heat or Steam Sterilization

[09421028111362]

Moist Heat or Steam Sterilization

[09421028111362]

Moist Heat or Steam Sterilization

[09421028111362]

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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09421028111362 - Enztec Classic OCI - Tornier Trinket2026-01-14 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028115643 - Enztec Classic OCI - Trinket 7 /16-20 UNF-022026-01-14 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
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09421038411612 - Offset Acetabular Shell Impactor Hex Driver - Enztec2025-12-29 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
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