MODULAR BROACH HANDLE, STRIKE PLATE 6270.2004

GUDID 09421028119092

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

ENZTEC LIMITED

Surgical instrument handle, non-torque-limiting
Primary Device ID09421028119092
NIH Device Record Key618a718e-5c4b-48c5-9425-420bbe678f92
Commercial Distribution StatusIn Commercial Distribution
Brand NameMODULAR BROACH HANDLE, STRIKE PLATE
Version Model Number6270.2004
Catalog Number6270.2004
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
GS109421028119092 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421028119092]

Moist Heat or Steam Sterilization


[09421028119092]

Moist Heat or Steam Sterilization


[09421028119092]

Moist Heat or Steam Sterilization


[09421028119092]

Moist Heat or Steam Sterilization


[09421028119092]

Moist Heat or Steam Sterilization


[09421028119092]

Moist Heat or Steam Sterilization


[09421028119092]

Moist Heat or Steam Sterilization


[09421028119092]

Moist Heat or Steam Sterilization


[09421028119092]

Moist Heat or Steam Sterilization


[09421028119092]

Moist Heat or Steam Sterilization


[09421028119092]

Moist Heat or Steam Sterilization


[09421028119092]

Moist Heat or Steam Sterilization


[09421028119092]

Moist Heat or Steam Sterilization


[09421028119092]

Moist Heat or Steam Sterilization


[09421028119092]

Moist Heat or Steam Sterilization


[09421028119092]

Moist Heat or Steam Sterilization


[09421028119092]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-04
Device Publish Date2024-11-26

Devices Manufactured by ENZTEC LIMITED

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09421028112536 - Enztec Classic OCI - Trinket 5/16-24 UNF-022026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028113540 - Enztec Classic OCI - Trinket 3/8-16 UNC-012026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028113557 - Enztec Classic OCI - Trinket 5/16-24 UNF-012026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028113571 - Enztec Classic OCI - Trinket 3/8-24 UNF-012026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421038410516 - ATTUNE FEMORAL IMPACTOR2026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421038410523 - ATTUNE FEMORAL IMPACTOR HEAD2026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure

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