Tandry Locking Plate System

GUDID 04719873106608

3.5mm Locking Distal Clavicle Plate, 13 Holes, Right

MICROWARE PRECISION CO., LTD.

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID04719873106608
NIH Device Record Key0ba33a85-94ae-4e40-89d4-f19857940adc
Commercial Distribution StatusIn Commercial Distribution
Brand NameTandry Locking Plate System
Version Model NumberT2-04-112-018
Company DUNS658650833
Company NameMICROWARE PRECISION CO., LTD.
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

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
GS104719873106608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04719873106608]

Moist Heat or Steam Sterilization

[04719873106608]

Moist Heat or Steam Sterilization

[04719873106608]

Moist Heat or Steam Sterilization

[04719873106608]

Moist Heat or Steam Sterilization

[04719873106608]

Moist Heat or Steam Sterilization

[04719873106608]

Moist Heat or Steam Sterilization

[04719873106608]

Moist Heat or Steam Sterilization

[04719873106608]

Moist Heat or Steam Sterilization

[04719873106608]

Moist Heat or Steam Sterilization

[04719873106608]

Moist Heat or Steam Sterilization

[04719873106608]

Moist Heat or Steam Sterilization

[04719873106608]

Moist Heat or Steam Sterilization

[04719873106608]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-23
Device Publish Date2025-09-15

On-Brand Devices [Tandry Locking Plate System]

047198731062263.5mm Locking Distal Fibula Plate, 4 Holes, Right
047198731055193.5mm Locking One-third Tubular Plate, 10 Holes
047198731054963.5mm Locking One-third Tubular Plate, 8 Holes
047198731054723.5mm Locking One-third Tubular Plate, 6 Holes
04719873103270Locking Screw 3.5mm, 30mm, Hexalobular
04719873103263Locking Screw 3.5mm, 28mm, Hexalobular
04719873103256Locking Screw 3.5mm, 26mm, Hexalobular
04719873103249Locking Screw 3.5mm, 24mm, Hexalobular
04719873103232Locking Screw 3.5mm, 22mm, Hexalobular
04719873103225Locking Screw 3.5mm, 20mm, Hexalobular
04719873103218Locking Screw 3.5mm, 18mm, Hexalobular
04719873103201Locking Screw 3.5mm, 16mm, Hexalobular
04719873103188Locking Screw 3.5mm, 12mm, Hexalobular
04719873103171Locking Screw 3.5mm, 10mm, Hexalobular
04719873103010Locking Screw 2.4mm, 30mm, Hexalobular
04719873103003Locking Screw 2.4mm, 28mm, Hexalobular
04719873102990Locking Screw 2.4mm, 26mm, Hexalobular
04719873102983Locking Screw 2.4mm, 24mm, Hexalobular
04719873102976Locking Screw 2.4mm, 22mm, Hexalobular
04719873102969Locking Screw 2.4mm, 20mm, Hexalobular
04719873102952Locking Screw 2.4mm, 18mm, Hexalobular
04719873102945Locking Screw 2.4mm, 16mm, Hexalobular
04719873102938Locking Screw 2.4mm, 14mm, Hexalobular
04719873102921Locking Screw 2.4mm, 12mm, Hexalobular
04719873102914Locking Screw 2.4mm, 10mm, Hexalobular
04719873102778Locking Screw 2.0mm, 18mm, Hexalobular
04719873102761Locking Screw 2.0mm, 16mm, Hexalobular
04719873102754Locking Screw 2.0mm, 14mm, Hexalobular
04719873102747Locking Screw 2.0mm, 13mm, Hexalobular
04719873102730Locking Screw 2.0mm, 12mm, Hexalobular
04719873102723Locking Screw 2.0mm, 11mm, Hexalobular
04719873102716Locking Screw 2.0mm, 10mm, Hexalobular
04719873102648Locking Screw 1.5mm, 20mm, Hexalobular
04719873102631Locking Screw 1.5mm, 18mm, Hexalobular
04719873102624Locking Screw 1.5mm, 16mm, Hexalobular
04719873102600Locking Screw 1.5mm, 14mm, Hexalobular
04719873102594Locking Screw 1.5mm, 13mm, Hexalobular
04719873102587Locking Screw 1.5mm, 12mm, Hexalobular
04719873102570Locking Screw 1.5mm, 11mm, Hexalobular
04719873102563Locking Screw 1.5mm, 10mm, Hexalobular
04719873102556Locking Screw 1.5mm, 9mm, Hexalobular
04719873102549Locking Screw 1.5mm, 8mm, Hexalobular
04719873102532Locking Screw 1.5mm, 7mm, Hexalobular
04719873102525Locking Screw 1.5mm, 6mm, Hexalobular
047198730986443.5mm Locking Superior Clavicle Plate, 8 Holes, Left
047198730986373.5mm Locking Superior Clavicle Plate, 8 Holes, Right
047198730986203.5mm Locking Superior Clavicle Plate, 7 Holes, Left
047198730986133.5mm Locking Superior Clavicle Plate, 7 Holes, Right
047198730986063.5mm Locking Superior Clavicle Plate, 6 Holes, Left
047198730985761.5mm Locking T Plate, 11 Holes
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