Enztec Inverted Premium Patella Clamp 4240-4328

GUDID 09421038410479

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

ENZTEC LIMITED

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID09421038410479
NIH Device Record Key6b0906fe-6802-4a70-a130-20fce07d3636
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnztec Inverted Premium Patella Clamp
Version Model Number4240-4328
Catalog Number4240-4328
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
GS109421038410479 [Primary]

FDA Product Code

HXDClamp

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421038410479]

Moist Heat or Steam Sterilization


[09421038410479]

Moist Heat or Steam Sterilization


[09421038410479]

Moist Heat or Steam Sterilization


[09421038410479]

Moist Heat or Steam Sterilization


[09421038410479]

Moist Heat or Steam Sterilization


[09421038410479]

Moist Heat or Steam Sterilization


[09421038410479]

Moist Heat or Steam Sterilization


[09421038410479]

Moist Heat or Steam Sterilization


[09421038410479]

Moist Heat or Steam Sterilization


[09421038410479]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-19
Device Publish Date2025-12-11

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
09421038410530 - Enztec Trinket M8x1.00-032026-01-13 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421038411612 - Offset Acetabular Shell Impactor Hex Driver - Enztec2025-12-29 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421038411629 - Offset Acetabular Shell Impactor Trinket - Enztec2025-12-29 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure

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