OIC Intramedullary Screw System

GUDID 10811998031719

4.5mm X 40mm METACARPAL NAIL

ORTHOPAEDIC IMPLANT COMPANY, THE

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID10811998031719
NIH Device Record Key6618a17f-dc6a-4d20-a767-cdee506f5418
Commercial Distribution StatusIn Commercial Distribution
Brand NameOIC Intramedullary Screw System
Version Model NumberMCN-4540
Company DUNS070061160
Company NameORTHOPAEDIC IMPLANT COMPANY, THE
Device Count1
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
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com

Device Dimensions

Length40 Millimeter
Outer Diameter4.5 Millimeter
Length40 Millimeter
Outer Diameter4.5 Millimeter
Length40 Millimeter
Outer Diameter4.5 Millimeter
Length40 Millimeter
Outer Diameter4.5 Millimeter
Length40 Millimeter
Outer Diameter4.5 Millimeter
Length40 Millimeter
Outer Diameter4.5 Millimeter
Length40 Millimeter
Outer Diameter4.5 Millimeter
Length40 Millimeter
Outer Diameter4.5 Millimeter
Length40 Millimeter
Outer Diameter4.5 Millimeter
Length40 Millimeter
Outer Diameter4.5 Millimeter
Length40 Millimeter
Outer Diameter4.5 Millimeter
Length40 Millimeter
Outer Diameter4.5 Millimeter
Length40 Millimeter
Outer Diameter4.5 Millimeter
Length40 Millimeter
Outer Diameter4.5 Millimeter
Length40 Millimeter
Outer Diameter4.5 Millimeter
Length40 Millimeter
Outer Diameter4.5 Millimeter
Length40 Millimeter
Outer Diameter4.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110811998031719 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10811998031719]

Moist Heat or Steam Sterilization

[10811998031719]

Moist Heat or Steam Sterilization

[10811998031719]

Moist Heat or Steam Sterilization

[10811998031719]

Moist Heat or Steam Sterilization

[10811998031719]

Moist Heat or Steam Sterilization

[10811998031719]

Moist Heat or Steam Sterilization

[10811998031719]

Moist Heat or Steam Sterilization

[10811998031719]

Moist Heat or Steam Sterilization

[10811998031719]

Moist Heat or Steam Sterilization

[10811998031719]

Moist Heat or Steam Sterilization

[10811998031719]

Moist Heat or Steam Sterilization

[10811998031719]

Moist Heat or Steam Sterilization

[10811998031719]

Moist Heat or Steam Sterilization

[10811998031719]

Moist Heat or Steam Sterilization

[10811998031719]

Moist Heat or Steam Sterilization

[10811998031719]

Moist Heat or Steam Sterilization

[10811998031719]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-14
Device Publish Date2023-09-06

On-Brand Devices [OIC Intramedullary Screw System]

10811998031856MCN STERILIZATION TRAY
108119980318493.3mm x 110mm CANNULATED DRILL BIT
108119980318322.6mm x 90mm CANNULATED DRILL BIT
108119980318251.15mm x 150mm K-WIRE
10811998031818T10 CANNULATED DRIVER
10811998031801METACARPAL NAIL DEPTH GAUGE
108119980317574.5mm X 60mm METACARPAL NAIL
108119980317404.5mm X 55mm METACARPAL NAIL
108119980317334.5mm X 50mm METACARPAL NAIL
108119980317264.5mm X 45mm METACARPAL NAIL
108119980317194.5mm X 40mm METACARPAL NAIL
108119980316653.6mm X 55mm METACARPAL NAIL
108119980316583.6mm X 50mm METACARPAL NAIL
108119980316413.6mm X 45mm METACARPAL NAIL
108119980316343.6mm X 40mm METACARPAL NAIL
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