Nextremity General Instrument

GUDID 00817701028482

Lapidus Cut Guide Disposable Set

NEXTREMITY SOLUTIONS, INC.

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Primary Device ID00817701028482
NIH Device Record Keyf1412c31-d948-4ac0-b032-61272aa1c36e
Commercial Distribution StatusIn Commercial Distribution
Brand NameNextremity General Instrument
Version Model NumberLCGKIT
Company DUNS060783407
Company NameNEXTREMITY SOLUTIONS, INC.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817701028482 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-12
Device Publish Date2022-05-04

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