Enztec Classic OCI – Corin Hex Driver 3991055003

GUDID 09421028111331

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

ENZTEC LIMITED

Orthopaedic implant impactor, reusable
Primary Device ID09421028111331
NIH Device Record Keyd8cb8bef-91db-4366-b56a-85c8051bd430
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnztec Classic OCI – Corin Hex Driver
Version Model Number3991055003
Catalog Number3991055003
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
GS109421028111331 [Primary]

FDA Product Code

HWAImpactor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

Moist Heat or Steam Sterilization

[09421028111331]

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

09421038412145 - Cup reamer handle, offset, Z/H, locking2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
09421038412152 - Offset coupling, Z/H2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
09421038412169 - Offset drive train, locking2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
09421038412176 - Short Offset Cover – United2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
09421038412183 - Handle – United2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
09421038412299 - Cup reamer handle, offset, AO, locking2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
09421038412305 - Offset coupling, AO2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
09421038412312 - Cup reamer handle, offset, AO, open2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
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