Caliber Intramedullary Fixation System

GUDID 00810005668040

Double Trocar 1.4mm kwire

NVISION BIOMEDICAL TECHNOLOGIES, INC.

General internal orthopaedic fixation system implantation kit
Primary Device ID00810005668040
NIH Device Record Key879ed9de-4626-402b-9cc6-eaabb93e3f3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCaliber Intramedullary Fixation System
Version Model NumberKWIRE-14-230D
Company DUNS047486041
Company NameNVISION BIOMEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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

Phone210-598-5938
EmailDenisealva@nvisionbiomed.com
Phone210-598-5938
EmailDenisealva@nvisionbiomed.com
Phone210-598-5938
EmailDenisealva@nvisionbiomed.com
Phone210-598-5938
EmailDenisealva@nvisionbiomed.com
Phone210-598-5938
EmailDenisealva@nvisionbiomed.com
Phone210-598-5938
EmailDenisealva@nvisionbiomed.com
Phone210-598-5938
EmailDenisealva@nvisionbiomed.com
Phone210-598-5938
EmailDenisealva@nvisionbiomed.com
Phone210-598-5938
EmailDenisealva@nvisionbiomed.com
Phone210-598-5938
EmailDenisealva@nvisionbiomed.com
Phone210-598-5938
EmailDenisealva@nvisionbiomed.com
Phone210-598-5938
EmailDenisealva@nvisionbiomed.com
Phone210-598-5938
EmailDenisealva@nvisionbiomed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810005668040 [Primary]

FDA Product Code

MDMInstrument, Manual, Surgical, General Use

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810005668040]

Moist Heat or Steam Sterilization


[00810005668040]

Moist Heat or Steam Sterilization


[00810005668040]

Moist Heat or Steam Sterilization


[00810005668040]

Moist Heat or Steam Sterilization


[00810005668040]

Moist Heat or Steam Sterilization


[00810005668040]

Moist Heat or Steam Sterilization


[00810005668040]

Moist Heat or Steam Sterilization


[00810005668040]

Moist Heat or Steam Sterilization


[00810005668040]

Moist Heat or Steam Sterilization


[00810005668040]

Moist Heat or Steam Sterilization


[00810005668040]

Moist Heat or Steam Sterilization


[00810005668040]

Moist Heat or Steam Sterilization


[00810005668040]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-29
Device Publish Date2025-07-21

On-Brand Devices [Caliber Intramedullary Fixation System]

00810135963114Caliber Intramedullary Fixation System Tray Assembly. The Caliber Intramedullary Fixation Syste
00810135963107Caliber Kwire Guide The Caliber Intramedullary Fixation System is an intramedullary bone fixatio
00810135963091Caliber Depth Gauge The Caliber Intramedullary Fixation System is an intramedullary bone fixatio
00810135963084Caliber Drill for 5.0 Implant The Caliber Intramedullary Fixation System is an intramedullary b
00810135963077Caliber Drill for 4.5 Implant The Caliber Intramedullary Fixation System is an intramedullary b
00810135963060Caliber Hex Drive Inserter The Caliber Intramedullary Fixation System is an intramedullary bone
00810135963053Caliber Inserter T15 Hexalobe The Caliber Intramedullary Fixation System is an intramedullary bo
00810135963046Caliber Multidrive Inserter The Caliber Intramedullary Fixation System is an intramedullary bone
008101359630395.0mm implant 120mm long. The Caliber Intramedullary Fixation System is an intramedullary bone f
008101359630225.0mm implant 110mm long. The Caliber Intramedullary Fixation System is an intramedullary bone f
008101359630155.0mm implant 100mm long. The Caliber Intramedullary Fixation System is an intramedullary bone f
008101359630085.0mm implant 90mm long. The Caliber Intramedullary Fixation System is an intramedullary bone fi
008101359629955.0mm implant 80mm long. The Caliber Intramedullary Fixation System is an intramedullary bone fi
008101359629884.5mm implant 120mm long. The Caliber Intramedullary Fixation System is an intramedullary bone f
008101359629714.5mm implant 110mm long. The Caliber Intramedullary Fixation System is an intramedullary bone f
008101359629644.5mm implant 100mm long. The Caliber Intramedullary Fixation System is an intramedullary bone f
008101359629574.5mm implant 90mm long. The Caliber Intramedullary Fixation System is an intramedullary bone fi
008101359629404.5mm implant 80mm long. The Caliber Intramedullary Fixation System is an intramedullary bone fi
00810005668040Double Trocar 1.4mm kwire

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