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

09421028119047 - Enztec Dual Mobility Head Press2025-03-05A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119047 - Enztec Dual Mobility Head Press2025-03-05 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421038410462 - Table Adaptor2025-03-05 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119269 - LEGION Kinematic Alignment Distal Valgus Guide2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119276 - JOURNEY Kinematic Alignment Distal Valgus Guide - Left2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119283 - JOURNEY Kinematic Alignment Distal Valgus Guide - Right2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119290 - Kinematic Alignment Caliper – S+N2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119306 - Distal Cartilage Shim – 2mm2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119313 - Varus/Valgus Recut Block – 2deg2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure

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