Naviagtion Instrumentation 01-1800-3002

GUDID 00840194427968

5.0mm Nav Guide Window Tap

ORTHOPEDIATRICS CORP.

Bone tap, reusable
Primary Device ID00840194427968
NIH Device Record Key59e544bb-2d29-44c5-a041-1b04d9c675e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameNaviagtion Instrumentation
Version Model Number01-1800-3002
Catalog Number01-1800-3002
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840194427968 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840194427968]

Moist Heat or Steam Sterilization


[00840194427968]

Moist Heat or Steam Sterilization


[00840194427968]

Moist Heat or Steam Sterilization


[00840194427968]

Moist Heat or Steam Sterilization


[00840194427968]

Moist Heat or Steam Sterilization


[00840194427968]

Moist Heat or Steam Sterilization


[00840194427968]

Moist Heat or Steam Sterilization


[00840194427968]

Moist Heat or Steam Sterilization


[00840194427968]

Moist Heat or Steam Sterilization


[00840194427968]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-07-02
Device Publish Date2022-12-15

On-Brand Devices [Naviagtion Instrumentation]

008401944279514.0mm Nav Guide Window Tap
008401944279995.5mm Nav Guide Window Tap
008401944279824.5mm Nav Guide Window Tap
008401944279756.0mm Nav Guide Window Tap
008401944279685.0mm Nav Guide Window Tap

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