1.6mm Guide Wire Smooth Trocar 230mm 320-80032

GUDID 00810074306140

1.6mm Guide Wire Smooth Trocar 230mm

Osteocentric Technologies, Inc.

Orthopaedic guidewire, single-use
Primary Device ID00810074306140
NIH Device Record Key34fe001e-c9c5-456e-971d-a1bcfb96ed91
Commercial Distribution StatusIn Commercial Distribution
Brand Name1.6mm Guide Wire Smooth Trocar 230mm
Version Model Number320-80032
Catalog Number320-80032
Company DUNS089645059
Company NameOsteocentric Technologies, Inc.
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com

Device Dimensions

Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter
Outer Diameter1.6 Millimeter
Length230 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810074306140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FZXGuide, Surgical, Instrument
HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


[00810074306140]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-16
Device Publish Date2024-12-06

Devices Manufactured by Osteocentric Technologies, Inc.

00810074300353 - 9mm Washer 0.9mm Height2025-05-26 9mm Washer 0.9mm Height
00810074306461 - 8.0mm Drill Bit Cann Hudson Mod 270mm2025-05-23 8.0mm Drill Bit Cann Hudson Mod 270mm
00810074306997 - 2.7mm Cortical Screw Tap 145mm2025-05-23 2.7mm Cortical Screw Tap 145mm
00810074307000 - 2.0mm Drill Calibrated 145mm2025-05-23 2.0mm Drill Calibrated 145mm
00816950029530 - Large Depth Gauge 125mm2025-05-23 Large Depth Gauge 125mm
00810074309219 - POST-LAT DISTAL FIBULA PLATE 2H L2025-05-19 POST-LAT DISTAL FIBULA PLATE 2H L
00810074309226 - POST-LAT DISTAL FIBULA PLATE 2H R2025-05-19 POST-LAT DISTAL FIBULA PLATE 2H R
00810074309233 - POST-LAT DISTAL FIBULA PLATE 4H L2025-05-19 POST-LAT DISTAL FIBULA PLATE 4H L

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.