Response 5.5/6.0 System 01-1300-6071

GUDID 00840194416597

Response 5.5/6.0 1-Piece Rocker

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00840194416597
NIH Device Record Keyba48f485-7abb-4d72-8935-4def31ad7111
Commercial Distribution StatusIn Commercial Distribution
Brand NameResponse 5.5/6.0 System
Version Model Number01-1300-6071
Catalog Number01-1300-6071
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840194416597 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840194416597]

Moist Heat or Steam Sterilization

[00840194416597]

Moist Heat or Steam Sterilization

[00840194416597]

Moist Heat or Steam Sterilization

[00840194416597]

Moist Heat or Steam Sterilization

[00840194416597]

Moist Heat or Steam Sterilization

[00840194416597]

Moist Heat or Steam Sterilization

[00840194416597]

Moist Heat or Steam Sterilization

[00840194416597]

Moist Heat or Steam Sterilization

[00840194416597]

Moist Heat or Steam Sterilization

[00840194416597]

Moist Heat or Steam Sterilization

[00840194416597]

Moist Heat or Steam Sterilization

[00840194416597]

Moist Heat or Steam Sterilization

[00840194416597]

Moist Heat or Steam Sterilization

[00840194416597]

Moist Heat or Steam Sterilization

[00840194416597]

Moist Heat or Steam Sterilization

[00840194416597]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-21
Device Publish Date2022-02-11

On-Brand Devices [Response 5.5/6.0 System]

00841132184615S-ROD (HL), Ø 6.0MM TI ALLOY, 500MM
008411321788745.5/6.0 Closed Screw Cap Right
008411321788505.5/6.0 Closed Screw Cap Left
00841132140321S-ROD (HL), Ø 5.5MM TI ALLOY, 500MM
00841132140291S-ROD (HL), Ø 6.0MM TI ALLOY, 400MM
00841132140284S-ROD (HL), Ø 5.5MM TI ALLOY, 400MM
00841132140253S-ROD, Ø 6.0MM TI ALLOY, 500MM, 80MM STRAIGHT
00841132140246S-ROD, Ø 6.0MM TI ALLOY, 500MM, 65MM STRAIGHT
00841132140239S-ROD, Ø 6.0MM TI ALLOY, 500MM, 50MM STRAIGHT
00841132140222S-ROD, Ø 5.5MM TI ALLOY, 500MM, 80MM STRAIGHT
00841132140215S-ROD, Ø 5.5MM TI ALLOY, 500MM, 65MM STRAIGHT
00841132140208S-ROD, Ø 5.5MM TI ALLOY, 500MM, 50MM STRAIGHT
00841132140055S-ROD, Ø 6.0MM TI ALLOY, 450MM, 80MM STRAIGHT
00841132140048S-ROD, Ø 6.0MM TI ALLOY, 450MM, 65MM STRAIGHT
00841132140031S-ROD, Ø 6.0MM TI ALLOY, 450MM, 50MM STRAIGHT
00841132140024S-ROD, Ø 5.5MM TI ALLOY, 450MM, 80MM STRAIGHT
00841132140017S-ROD, Ø 5.5MM TI ALLOY, 450MM, 65MM STRAIGHT
00841132140000S-ROD, Ø 5.5MM TI ALLOY, 450MM, 50MM STRAIGHT
00841132139998S-ROD, Ø 6.0MM TI ALLOY, 400MM, 80MM STRAIGHT
00841132139981S-ROD, Ø 6.0MM TI ALLOY, 400MM, 65MM STRAIGHT
00841132139974S-ROD, Ø 6.0MM TI ALLOY, 400MM, 50MM STRAIGHT
00841132139967S-ROD, Ø 5.5MM TI ALLOY, 400MM, 80MM STRAIGHT
00841132139950S-ROD, Ø 5.5MM TI ALLOY, 400MM, 65MM STRAIGHT
00841132139943S-ROD, Ø 5.5MM TI ALLOY, 400MM, 50MM STRAIGHT
00840194416597Response 5.5/6.0 1-Piece Rocker
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