Enztec Dual Mobility Head Press 4252-0001

GUDID 09421028119047

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

ENZTEC LIMITED

Orthopaedic implant/instrument assembling device
Primary Device ID09421028119047
NIH Device Record Key06bbda1e-d505-4d96-aa7e-093cd07190f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnztec Dual Mobility Head Press
Version Model Number4252-0001
Catalog Number4252-0001
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
GS109421028119047 [Primary]

FDA Product Code

HWNInstrument, Compression

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421028119047]

Moist Heat or Steam Sterilization


[09421028119047]

Moist Heat or Steam Sterilization


[09421028119047]

Moist Heat or Steam Sterilization


[09421028119047]

Moist Heat or Steam Sterilization


[09421028119047]

Moist Heat or Steam Sterilization


[09421028119047]

Moist Heat or Steam Sterilization


[09421028119047]

Moist Heat or Steam Sterilization


[09421028119047]

Moist Heat or Steam Sterilization


[09421028119047]

Moist Heat or Steam Sterilization


[09421028119047]

Moist Heat or Steam Sterilization


[09421028119047]

Moist Heat or Steam Sterilization


[09421028119047]

Moist Heat or Steam Sterilization


[09421028119047]

Moist Heat or Steam Sterilization


[09421028119047]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-05
Device Publish Date2025-02-25

Devices Manufactured by ENZTEC LIMITED

09421038410868 - Enztec Trinket M8x1.00-042025-06-06 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119948 - Enztec Premium Patella Clamp - Inverted2025-06-02 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119955 - Cement Clamp - Odev2025-06-02 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421038410615 - Patella Drill Guide – Restor3d Oval 29-352025-06-02 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421038410622 - Patella Drill Guide – Restor3d Oval 38-442025-06-02 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421038410639 - Patella Drill Guide – Restor3d Round 29-352025-06-02 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421038410646 - Patella Drill Guide – Restor3d Round 38-442025-06-02 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421038410554 - 3.5mm Ball Hex Driver – 225mm2025-04-21 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.