RESPONSE SPINE SYSTEM 01-1300-6024

GUDID 00841132175668

Hourglass Feeler Probe, Small

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00841132175668
NIH Device Record Key55b5ae32-86fe-4686-b7b6-056d263193d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameRESPONSE SPINE SYSTEM
Version Model Number01-1300-6024
Catalog Number01-1300-6024
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exempttrue
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@orthopediatric.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132175668 [Primary]

FDA Product Code

GFGBIT, SURGICAL
HXBPROBE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841132175668]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-17
Device Publish Date2020-03-05

On-Brand Devices [RESPONSE SPINE SYSTEM]

008411321774715.5/6.0 Polyaxial Caddy 1
008411321775635.5/6.0 Correction - Tray 2
008411321775565.5/6.0 Correction - Tray 1
008411321775495.5/6.0 Set Screw Caddy
00841132177532Response 4.5/5.0 Dual Set Screw Driver
008411321775255.5/6.0 Rod & Rod Reduction - Tray 1
008411321775186.0MM TAP, 25MM LENGTH, HUDSON
008411321773586.0mm Cannulated Tap, Double Lead, Square
008411321773415.5mm Cannulated Tap, Double Lead, Square
00841132177297Reduction Tab Breaker
00841132177280Lenke Probe, Handle
008411321772734.5/5.0 Rowe Poly Reduction Case
008411321772665.5/6.0 Rowe Poly Reduction Case
008411321771811/4 Drive Modular Lenke Probe
008411321768565.5/6.0 Hook & Connector - Hook Caddy
008411321768495.5/6.0 Hook & Connector - Connector Caddy
008411321768325.5/6.0 Hook & Connector - Tray 2
008411321768255.5/6.0 Hook & Connector - Tray 1
008411321768185.5/6.0 Correction - Tray 2
008411321768015.5/6.0 Correction - Tray 1
008411321767955.5/6.0 Set Screw Caddy
008411321767885.5/6.0 Rod & Rod Reduction - Tray 2
008411321767715.5/6.0 Rod & Rod Reduction - Tray 1
008411321767645.5/6.0 Pedicle Prep & Final Drive - Tray 3
008411321767575.5/6.0 Pedicle Prep & Final Drive - Tray 2
008411321767405.5/6.0 Pedicle Prep & Final Drive - Tray 1
008411321767335.5/6.0 Polyaxial Caddy 2
008411321767265.5/6.0 Polyaxial Caddy 1
008411321767195.5/6.0 Uniaxial Caddy 2
008411321767025.5/6.0 Uniaxial Caddy 1
00841132176597PEDICLE MARKER, MOD 30MM
00841132176580PEDICLE MARKER, MOD 15MM
00841132175675Hourglass Feeler Probe, Large
00841132175668Hourglass Feeler Probe, Small
00841132175651Hourglass Feeler Probe, Double
00841132174425Final Torque, Short, Power
008411321734806.0mm Solid Tap, Double Lead, Power
008411321734735.0mm Solid Tap, Double Lead, Power
008411321734664.0mm Solid Tap, Double Lead, Power
008411321734593.0mm Solid Tap, Double Lead, Power
00841132156490JIMINY DRIVER, MEDIUM
008411321564766.0mm Solid Tap, Single Lead, Power
008411321564695.5mm Solid Tap, Single Lead, Power
008411321564525.0mm Solid Tap, Single Lead, Power
008411321564454.5mm Solid Tap, Single Lead, Power
008411321564384.0mm Solid Tap, Single Lead, Power
008411321564213.5mm Solid Tap, Single Lead, Power
008411321564143.0mm Solid Tap, Single Lead, Power
008411321564076.0mm Solid Tap, Single Lead, Square
008411321563915.5mm Solid Tap, Single Lead, Square

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