DRPx Locking Distal Radius Plate System

GUDID 10811998039760

KICKSTAND GUIDE

ORTHOPAEDIC IMPLANT COMPANY, THE

Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable
Primary Device ID10811998039760
NIH Device Record Keyf948f26c-9a49-4989-8209-9bfcfd7bb92a
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRPx Locking Distal Radius Plate System
Version Model NumberOIC-NK1
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 Identifiers

Device Issuing AgencyDevice ID
GS110811998039760 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10811998039760]

Moist Heat or Steam Sterilization

[10811998039760]

Moist Heat or Steam Sterilization

[10811998039760]

Moist Heat or Steam Sterilization

[10811998039760]

Moist Heat or Steam Sterilization

[10811998039760]

Moist Heat or Steam Sterilization

[10811998039760]

Moist Heat or Steam Sterilization

[10811998039760]

Moist Heat or Steam Sterilization

[10811998039760]

Moist Heat or Steam Sterilization

[10811998039760]

Moist Heat or Steam Sterilization

[10811998039760]

Moist Heat or Steam Sterilization

[10811998039760]

Moist Heat or Steam Sterilization

[10811998039760]

Moist Heat or Steam Sterilization

[10811998039760]

Moist Heat or Steam Sterilization

[10811998039760]

Moist Heat or Steam Sterilization

[10811998039760]

Moist Heat or Steam Sterilization

[10811998039760]

Moist Heat or Steam Sterilization

[10811998039760]

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 [DRPx Locking Distal Radius Plate System]

10811998039463DRPX STERILIZATION CASE
10811998039524DORSAL SPANNING PLATE, 8H X 210MM
10811998039517DORSAL SPANNING PLATE, 8H X 160MM
10811998039494DRPX DORSAL SPANNING PLATE HANDLE
108119980392652.6MM X 12MM SELF-TAP CORTEX SCREW
108119980392582.6MM X 10MM SELF-TAP CORTEX SCREW
108119980392412.6MM X 8MM SELF-TAP CORTEX SCREW
108119980391042.6MM X 12MM VARIABLE ANGLE SCREW
108119980390982.6MM X 10MM VARIABLE ANGLE SCREW
108119980390812.6MM X 08MM VARIABLE ANGLE SCREW
10811998039777KICKSTAND SHAFT
10811998039760KICKSTAND GUIDE
10811998035755DISTAL RADIUS PLATE, STANDARD, 7H RIGHT
10811998035748DISTAL RADIUS PLATE, STANDARD, 7H LEFT
108119980397392.8MM X 95MM CALIBRATED DRILL BIT
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