Enztec Straight Cup Impactor 4252-2400

GUDID 09421028119023

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

ENZTEC LIMITED

Orthopaedic implant impactor, reusable
Primary Device ID09421028119023
NIH Device Record Keya748d78b-5cfd-4ea1-aa7d-6e3d1db70064
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnztec Straight Cup Impactor
Version Model Number4252-2400
Catalog Number4252-2400
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
GS109421028119023 [Primary]

FDA Product Code

HWAImpactor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


[09421028119023]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-08
Device Publish Date2024-02-29

Devices Manufactured by ENZTEC LIMITED

09421038410288 - Enztec Patella Shim - 4mm2024-12-09 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028118651 - Adjustable Cutting Block – 1.35mm2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028118668 - 3.5mm Ball Hex Driver – 340mm2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028118705 - MODULAR BROACH HANDLE, DUAL OFFSET, RIGHT2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028118712 - MODULAR BROACH HANDLE, DUAL OFFSET, LEFT2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119030 - Adjustable Cutting Block – 1.27mm2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119085 - MODULAR BROACH HANDLE, GRIP2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119092 - MODULAR BROACH HANDLE, STRIKE PLATE2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.