Syntec-Taichung Non-sterile Bone Plate and Screw Implants

GUDID 04719864684672

Straight Reconstruction Plate 3.5x 20Holes x L238mm

SYNTEC SCIENTIFIC CORPORATION

Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID04719864684672
NIH Device Record Key9def933b-afbc-4ebd-9d25-a9b4b5e83790
Commercial Distribution StatusIn Commercial Distribution
Brand NameSyntec-Taichung Non-sterile Bone Plate and Screw Implants
Version Model Number245100
Company DUNS657692971
Company NameSYNTEC SCIENTIFIC CORPORATION
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104719864684672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04719864684672]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-02-19
Device Publish Date2019-07-19

On-Brand Devices [Syntec-Taichung Non-sterile Bone Plate and Screw Implants]

04719864661369Cortex Screw φ2.0 x 38 mm
04719864661352Cortex Screw φ2.0 x 36 mm
04719864661345Cortex Screw φ2.0 x 34 mm
04719864661338Cortex Screw φ2.0 x 32 mm
04719864661321Cortex Screw φ2.0 x 30 mm
04719864661314Cortex Screw φ2.0 x 28 mm
04719864661307Cortex Screw φ2.0 x 26 mm
04719864661291Cortex Screw φ2.0 x 24 mm
04719864661284Cortex Screw φ2.0 x 22 mm
04719864661277Cortex Screw φ2.0 x 20 mm
04719864661260Cortex Screw φ2.0 x 18 mm
04719864661253Cortex Screw φ2.0 x 16 mm
04719864661246Cortex Screw φ2.0 x 14 mm
04719864661239Cortex Screw φ2.0 x 12 mm
04719864661222Cortex Screw φ2.0 x 10 mm
04719864661215Cortex Screw φ2.0 x 8 mm
04719864661208Cortex Screw φ 2.0 x 6 mm
04719864684467L & T-Plate(Left Obliqre) 2.0
04719864684672Straight Reconstruction Plate 3.5x 20Holes x L238mm

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