Drive Rail System 22-3050

GUDID 00817867020627

CLAMP, 5-HOLE IN-LINE

ORTHOPEDIATRICS CORP.

External orthopaedic fixation system, single-use
Primary Device ID00817867020627
NIH Device Record Key97363e0f-6123-4c26-9ad7-8b14cfecdfc3
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrive Rail System
Version Model Number22-3050
Catalog Number22-3050
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817867020627 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817867020627]

Moist Heat or Steam Sterilization


[00817867020627]

Moist Heat or Steam Sterilization


[00817867020627]

Moist Heat or Steam Sterilization


[00817867020627]

Moist Heat or Steam Sterilization


[00817867020627]

Moist Heat or Steam Sterilization


[00817867020627]

Moist Heat or Steam Sterilization


[00817867020627]

Moist Heat or Steam Sterilization


[00817867020627]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-27
Device Publish Date2022-06-17

On-Brand Devices [Drive Rail System]

0084019441121910mm Driver, Square Drive
00840194411158Allen Wrench 3/16"
00817867021006Hinge and Arch Tray
00817867020993Hinge and Arch Screw Caddy
008178670208873 mm 90° HEX WRENCH
00817867020856Rail and Clamp Screw Caddy
00817867020849Rail and Clamp Tray
00817867020832Lid
0081786702082510 mm AND 13 mm OPEN END WRENCH
00817867020801RAIL ASSEMBLY TOOL
0081786702079510 mm Ratchet Wrench
008178670207883/16" HEX DRIVER
00817867020771TORQUE T-HANDLE
0081786702076410 mm BOLT DRIVER
0081786702074010 mm COMBINATION WRENCH
008178670207333/16" L-HEX DRIVER
00817867020672SET SCREW
00817867020665SCREW, CLAMP TO CARRIAGE
00817867020658SCREW, SHORT, CLAMP TO CARRIAGE
00817867020641CLAMP, 2-HOLE ANGLE
00817867020634CLAMP, 7-HOLE STACKED (5, 2)
00817867020627CLAMP, 5-HOLE IN-LINE
00817867020610CLAMP, 5-HOLE STACKED (4, 1)
00817867020603CLAMP, 4-HOLE IN-LINE
00817867020597CLAMP, 3-HOLE IN-LINE
00817867020580CLAMP, 2-HOLE IN-LINE
00817867020573CLAMP, 1-HOLE
00817867020566RAIL END CAP
00817867020559CARRIAGE, RAIL ARCH
00817867020542CARRIAGE, STANDARD
00817867020535RAIL ENDCAP, ROTATING, 100 mm
00817867020528DRIVE MECHANISM COVER

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