Double Offset Right Woodpecker Adaptor M2 Connection 9095.11.055

GUDID 09421028112949

A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure

ENZTEC LIMITED

Surgical power tool adaptor
Primary Device ID09421028112949
NIH Device Record Keyf5a996ea-503e-44cd-b320-2fecbdfd002a
Commercial Distribution StatusIn Commercial Distribution
Brand NameDouble Offset Right Woodpecker Adaptor M2 Connection
Version Model Number9095.11.055
Catalog Number9095.11.055
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
GS109421028112949 [Primary]

FDA Product Code

HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421028112949]

Moist Heat or Steam Sterilization


[09421028112949]

Moist Heat or Steam Sterilization


[09421028112949]

Moist Heat or Steam Sterilization


[09421028112949]

Moist Heat or Steam Sterilization


[09421028112949]

Moist Heat or Steam Sterilization


[09421028112949]

Moist Heat or Steam Sterilization


[09421028112949]

Moist Heat or Steam Sterilization


[09421028112949]

Moist Heat or Steam Sterilization


[09421028112949]

Moist Heat or Steam Sterilization


[09421028112949]

Moist Heat or Steam Sterilization


[09421028112949]

Moist Heat or Steam Sterilization


[09421028112949]

Moist Heat or Steam Sterilization


[09421028112949]

Moist Heat or Steam Sterilization


[09421028112949]

Moist Heat or Steam Sterilization


[09421028112949]

Moist Heat or Steam Sterilization


[09421028112949]

Moist Heat or Steam Sterilization


[09421028112949]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-13
Device Publish Date2023-12-05

Devices Manufactured by ENZTEC LIMITED

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09421028119924 - Enztec Trinket M8x1.25-012024-09-02 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028115056 - Enztec Cup Impactor Alignment Guide - Supine2024-08-23 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028115063 - Enztec Cup Impactor Alignment Guide - Lateral2024-08-23 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure

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