OIC Intramedullary Nail System

GUDID 10811998038114

4.0MM X 155MM RADIOLUCENT TWIST DRILL BIT

ORTHOPAEDIC IMPLANT COMPANY, THE

Fluted surgical drill bit, reusable
Primary Device ID10811998038114
NIH Device Record Keyff076a46-a532-4e9c-8171-9ef0f0da6fb3
Commercial Distribution StatusIn Commercial Distribution
Brand NameOIC Intramedullary Nail System
Version Model NumberCD40-155C
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

Device Dimensions

Length155 Millimeter
Outer Diameter4 Millimeter
Length155 Millimeter
Outer Diameter4 Millimeter
Length155 Millimeter
Outer Diameter4 Millimeter
Length155 Millimeter
Outer Diameter4 Millimeter
Length155 Millimeter
Outer Diameter4 Millimeter
Length155 Millimeter
Outer Diameter4 Millimeter
Length155 Millimeter
Outer Diameter4 Millimeter
Length155 Millimeter
Outer Diameter4 Millimeter
Length155 Millimeter
Outer Diameter4 Millimeter
Length155 Millimeter
Outer Diameter4 Millimeter
Length155 Millimeter
Outer Diameter4 Millimeter
Length155 Millimeter
Outer Diameter4 Millimeter
Length155 Millimeter
Outer Diameter4 Millimeter
Length155 Millimeter
Outer Diameter4 Millimeter
Length155 Millimeter
Outer Diameter4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110811998038114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10811998038114]

Moist Heat or Steam Sterilization

[10811998038114]

Moist Heat or Steam Sterilization

[10811998038114]

Moist Heat or Steam Sterilization

[10811998038114]

Moist Heat or Steam Sterilization

[10811998038114]

Moist Heat or Steam Sterilization

[10811998038114]

Moist Heat or Steam Sterilization

[10811998038114]

Moist Heat or Steam Sterilization

[10811998038114]

Moist Heat or Steam Sterilization

[10811998038114]

Moist Heat or Steam Sterilization

[10811998038114]

Moist Heat or Steam Sterilization

[10811998038114]

Moist Heat or Steam Sterilization

[10811998038114]

Moist Heat or Steam Sterilization

[10811998038114]

Moist Heat or Steam Sterilization

[10811998038114]

Moist Heat or Steam Sterilization

[10811998038114]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-03
Device Publish Date2021-05-26

On-Brand Devices [OIC Intramedullary Nail System]

M69601IM480EXTRACTION BOLT
10811998036554EXTRACTION BOLT, FEMUR
10811998036462EXTRACTION BOLT
10811998038084BALL TIP GUIDE ROD 3.0MM X 800MM (PACK OF 10)
10811998038138127.5 DEGREE HIP NAIL 10MM X 180MM
10811998038121SET SCREW EXTRACTION TOOL, 4.5MM HEX
108119980381144.0MM X 155MM RADIOLUCENT TWIST DRILL BIT
10811998038107127.5 DEGREE HIP NAIL 11MM X 440MM RIGHT
10811998038091127.5 DEGREE HIP NAIL 11MM X 440MM LEFT
M69601TIB010STERILIZATION CASE IM NAIL TIBIA TRAY
M69601IM550STERILIZATION CASE IM NAIL LONG HIP NAILS TRAY
M69601IM540STERILIZATION CASE IM NAIL HIP AND FEMUR TRAY
M69601IM000STERILIZATION CASE IM NAIL BASE TRAY
M69601ARFN0010STERILIZATION CASE IM NAIL ARFN TRAY
10811998036585STERILIZATION CASE IM TIBIA NAILS
10811998036578STERILIZATION CASE IM NAIL EXTRACTION SET TRAY
10811998036530STERILIZATION CASE IM NAIL LONG HIP NAILS TRAY
10811998036523STERILIZATION CASE IM NAIL HIP AND FEMUR TRAY
10811998036011STERILIZATION CASE IM NAIL BASE TRAY
10811998036004STERILIZATION CASE IM NAIL ARFN TRAY
10811998038145127.5 DEGREE HIP NAIL 10MM X 210MM
M69601IM520IM NAIL REDUCTION TOOL
M69601IM010T-HANDLE AWL
10811998036509IM NAIL REDUCTION TOOL
10811998036028T-HANDLE AWL
1081199803816910 mm x 600 mm FUSION NAIL, RIGHT
1081199803815210 mm x 600 mm FUSION NAIL, LEFT
M696GW031000S0BALL TIP GUIDE ROD 3.0MM X 1000MM
10811998036851BALL TIP GUIDE ROD 3.0MM X 1000MM
10811998036844BALL TIP GUIDE ROD 3.0MM X 1000MM
10811998039937TIBIAL NAIL 10MM X 350MM
10811998039920TIBIAL NAIL 10MM X 330MM
10811998039913TIBIAL NAIL 9MM X 350MM
10811998039906TIBIAL NAIL 9MM X 330MM
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