Response Navigation 01-1800-3035

GUDID 00841132181065

3.5mm Tap, Single Lead, Navigation

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00841132181065
NIH Device Record Keyd64323c0-ffdb-449e-8dd6-49757f832628
Commercial Distribution StatusIn Commercial Distribution
Brand NameResponse Navigation
Version Model Number01-1800-3035
Catalog Number01-1800-3035
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

Customer Support Contacts

Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132181065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841132181065]

Moist Heat or Steam Sterilization

[00841132181065]

Moist Heat or Steam Sterilization

[00841132181065]

Moist Heat or Steam Sterilization

[00841132181065]

Moist Heat or Steam Sterilization

[00841132181065]

Moist Heat or Steam Sterilization

[00841132181065]

Moist Heat or Steam Sterilization

[00841132181065]

Moist Heat or Steam Sterilization

[00841132181065]

Moist Heat or Steam Sterilization

[00841132181065]

Moist Heat or Steam Sterilization

[00841132181065]

Moist Heat or Steam Sterilization

[00841132181065]

Moist Heat or Steam Sterilization

[00841132181065]

Moist Heat or Steam Sterilization

[00841132181065]

Moist Heat or Steam Sterilization

[00841132181065]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-04
Device Publish Date2021-02-24

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