Tandry Orthopedic Manual Surgical Instrument

GUDID 04719879398045

SELF-RETAINING T15 SCREWDRIVER SHAFT

MICROWARE PRECISION CO., LTD.

Surgical screwdriver, reusable
Primary Device ID04719879398045
NIH Device Record Key838578f8-7dc4-47fe-8255-0b9c4079582a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTandry Orthopedic Manual Surgical Instrument
Version Model Number303012A-K00
Company DUNS658650833
Company NameMICROWARE PRECISION CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Phone+886424636275
Emailharrisondu@microware.com.tw
Phone+886424636275
Emailharrisondu@microware.com.tw
Phone+886424636275
Emailharrisondu@microware.com.tw
Phone+886424636275
Emailharrisondu@microware.com.tw
Phone+886424636275
Emailharrisondu@microware.com.tw
Phone+886424636275
Emailharrisondu@microware.com.tw
Phone+886424636275
Emailharrisondu@microware.com.tw
Phone+886424636275
Emailharrisondu@microware.com.tw
Phone+886424636275
Emailharrisondu@microware.com.tw
Phone+886424636275
Emailharrisondu@microware.com.tw
Phone+886424636275
Emailharrisondu@microware.com.tw
Phone+886424636275
Emailharrisondu@microware.com.tw
Phone+886424636275
Emailharrisondu@microware.com.tw
Phone+886424636275
Emailharrisondu@microware.com.tw
Phone+886424636275
Emailharrisondu@microware.com.tw
Phone+886424636275
Emailharrisondu@microware.com.tw

Device Identifiers

Device Issuing AgencyDevice ID
GS104719879398045 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04719879398045]

Moist Heat or Steam Sterilization


[04719879398045]

Moist Heat or Steam Sterilization


[04719879398045]

Moist Heat or Steam Sterilization


[04719879398045]

Moist Heat or Steam Sterilization


[04719879398045]

Moist Heat or Steam Sterilization


[04719879398045]

Moist Heat or Steam Sterilization


[04719879398045]

Moist Heat or Steam Sterilization


[04719879398045]

Moist Heat or Steam Sterilization


[04719879398045]

Moist Heat or Steam Sterilization


[04719879398045]

Moist Heat or Steam Sterilization


[04719879398045]

Moist Heat or Steam Sterilization


[04719879398045]

Moist Heat or Steam Sterilization


[04719879398045]

Moist Heat or Steam Sterilization


[04719879398045]

Moist Heat or Steam Sterilization


[04719879398045]

Moist Heat or Steam Sterilization


[04719879398045]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-15
Device Publish Date2025-05-07

On-Brand Devices [Tandry Orthopedic Manual Surgical Instrument]

04719879398311HANDLE WITH QUICK COUPLING, LENGTH 110mm, CANNULATED SCREWS 4.0mm
04719879398045SELF-RETAINING T15 SCREWDRIVER SHAFT
04719879398007DOUBLE DRILL GUIDE 3.5/2.5, FOR DRILL BITS Ø3.5/2.5mm
04719879397987DEPTH GAUGE FOR SCREW Ø2.7 TO 4.0mm, MEASURING RANGE UP TO 60mm

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