ACL 01-1008-2530

GUDID 00841132124277

2.5MM X 300MM GUIDE WIRE, SMOOTH, COCR

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00841132124277
NIH Device Record Key4b4c536c-07c8-43c9-afcf-c431b689994c
Commercial Distribution StatusIn Commercial Distribution
Brand NameACL
Version Model Number01-1008-2530
Catalog Number01-1008-2530
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 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
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
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132124277 [Primary]

FDA Product Code

FZHApparatus, air handling, room

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841132124277]

Moist Heat or Steam Sterilization


[00841132124277]

Moist Heat or Steam Sterilization


[00841132124277]

Moist Heat or Steam Sterilization


[00841132124277]

Moist Heat or Steam Sterilization


[00841132124277]

Moist Heat or Steam Sterilization


[00841132124277]

Moist Heat or Steam Sterilization


[00841132124277]

Moist Heat or Steam Sterilization


[00841132124277]

Moist Heat or Steam Sterilization


[00841132124277]

Moist Heat or Steam Sterilization


[00841132124277]

Moist Heat or Steam Sterilization


[00841132124277]

Moist Heat or Steam Sterilization


[00841132124277]

Moist Heat or Steam Sterilization


[00841132124277]

Moist Heat or Steam Sterilization


[00841132124277]

Moist Heat or Steam Sterilization


[00841132124277]

Moist Heat or Steam Sterilization


[00841132124277]

Moist Heat or Steam Sterilization


[00841132124277]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-14
Device Publish Date2021-07-06

Devices Manufactured by ORTHOPEDIATRICS CORP.

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00840194418256 - Response 5.5/6.02025-06-05 Response 5.5/6.0 Pedicle Screw Driver, ZH Drive
00840194444842 - PNP Femur2025-06-05 2.0mm Smooth Guide Wire, 800mm
00840194444866 - PNP Femur2025-06-05 Exchange Tube
00840194469852 - PNP Tibia2025-06-05 PNP 4.0mm x 15mm Fully Threaded Screw, Ti
00840194469869 - PNP Tibia2025-06-05 PNP 4.0mm x 17.5mm Fully Threaded Screw, Ti
00840194469876 - PNP Tibia2025-06-05 PNP 4.0mm x 20mm Fully Threaded Screw, Ti
00840194469883 - PNP Tibia2025-06-05 PNP 4.0mm x 22.5mm Fully Threaded Screw, Ti

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