Hudson Large AO Adaptor 900020112

GUDID 09421028118583

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 ID09421028118583
NIH Device Record Key48b69f5b-0b6e-4d8c-9a0a-3696acd41869
Commercial Distribution StatusIn Commercial Distribution
Brand NameHudson Large AO Adaptor
Version Model Number900020112
Catalog Number900020112
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
GS109421028118583 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


[09421028118583]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-08
Device Publish Date2023-10-31

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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

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