MAXIMA ACP SYSTEM

GUDID 08800037550835

U&I CORPORATION

Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver
Primary Device ID08800037550835
NIH Device Record Keyd90baed4-c25d-4fa2-bae6-bffaffa06935
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAXIMA ACP SYSTEM
Version Model NumberSC7170
Company DUNS688811082
Company NameU&I CORPORATION
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 Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800037550835 [Primary]

FDA Product Code

FZXGuide, surgical, instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


[08800037550835]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-06
Device Publish Date2021-07-29

On-Brand Devices [MAXIMA ACP SYSTEM]

08800037550842SC7171
08800037550835SC7170

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