Dual Mobility Head Press - Head Holder 4252-0007

GUDID 09421038411575

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

ENZTEC LIMITED

Orthopaedic implant/instrument assembling device
Primary Device ID09421038411575
NIH Device Record Keybffc5a2f-4355-44a1-9f08-5996f639d5dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameDual Mobility Head Press - Head Holder
Version Model Number4252-0007
Catalog Number4252-0007
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
GS109421038411575 [Primary]

FDA Product Code

HWNInstrument, Compression

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421038411575]

Moist Heat or Steam Sterilization


[09421038411575]

Moist Heat or Steam Sterilization


[09421038411575]

Moist Heat or Steam Sterilization


[09421038411575]

Moist Heat or Steam Sterilization


[09421038411575]

Moist Heat or Steam Sterilization


[09421038411575]

Moist Heat or Steam Sterilization


[09421038411575]

Moist Heat or Steam Sterilization


[09421038411575]

Moist Heat or Steam Sterilization


[09421038411575]

Moist Heat or Steam Sterilization


[09421038411575]

Moist Heat or Steam Sterilization


[09421038411575]

Moist Heat or Steam Sterilization


[09421038411575]

Moist Heat or Steam Sterilization


[09421038411575]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-06
Device Publish Date2025-09-26

Devices Manufactured by ENZTEC LIMITED

09421028119054 - Neck Holder2025-10-06 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119061 - Base2025-10-06 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119078 - Head Holder2025-10-06 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119849 - Patella Drill Guide – Symbios XS-S-M2025-10-06 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119856 - Patella Drill Guide – Symbios L - XL2025-10-06 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119863 - Cement Clamp – Symbios XS-S2025-10-06 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119870 - Cement Clamp – Symbios M-L-XL2025-10-06 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119887 - Cement Clamp Pad – Symbios XS-S2025-10-06 A reusable 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.