Response 5.5, Response 5.5/6.0 03-1300-8521

GUDID 00840194478397

Extended Mini-Reducer - Tray 2

ORTHOPEDIATRICS CORP.

Instrument tray, reusable
Primary Device ID00840194478397
NIH Device Record Keybed85823-bbdb-4dae-a8ac-716346eb387a
Commercial Distribution StatusIn Commercial Distribution
Brand NameResponse 5.5, Response 5.5/6.0
Version Model Number03-1300-8521
Catalog Number03-1300-8521
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840194478397 [Primary]

FDA Product Code

FSMTRAY, SURGICAL, INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840194478397]

Moist Heat or Steam Sterilization


[00840194478397]

Moist Heat or Steam Sterilization


[00840194478397]

Moist Heat or Steam Sterilization


[00840194478397]

Moist Heat or Steam Sterilization


[00840194478397]

Moist Heat or Steam Sterilization


[00840194478397]

Moist Heat or Steam Sterilization


[00840194478397]

Moist Heat or Steam Sterilization


[00840194478397]

Moist Heat or Steam Sterilization


[00840194478397]

Moist Heat or Steam Sterilization


[00840194478397]

Moist Heat or Steam Sterilization


[00840194478397]

Moist Heat or Steam Sterilization


[00840194478397]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-15
Device Publish Date2024-07-05

On-Brand Devices [Response 5.5, Response 5.5/6.0]

00840194487450Extended Mini-Reducer Wing Nut
00840194478533Extended Mini-Reducer Handle
00840194478526Extended Mini-Reducer Locking Derotation Handle
008401944785195.5/6.0 Extended Mini-Reducer
00840194478397Extended Mini-Reducer - Tray 2
00840194478380Extended Mini-Reducer - Tray 1
00840194480239Counter Torque - Extended Mini-Reducer
00840194493918Extended Mini-Reducer Long Handle

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