OIC IM NAIL SYSTEM

GUDID 20811998036599

CALIBRATED GUIDE PIN 3.2MM X 400MM

ORTHOPAEDIC IMPLANT COMPANY, THE

Orthopaedic bone wire Orthopaedic bone wire
Primary Device ID20811998036599
NIH Device Record Key7353fda8-5bcf-42b3-8aca-b4dc16d2ed8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameOIC IM NAIL SYSTEM
Version Model Number32-400P
Company DUNS070061160
Company NameORTHOPAEDIC IMPLANT COMPANY, THE
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110811998036592 [Unit of Use]
GS120811998036599 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[20811998036599]

Moist Heat or Steam Sterilization


[20811998036599]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-31
Device Publish Date2018-07-31

On-Brand Devices [OIC IM NAIL SYSTEM]

20811998036599CALIBRATED GUIDE PIN 3.2MM X 400MM
108119980365923.2 mm X 400 mm CALIBRATED GUIDEPIN (SINGLE UNIT)

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