POYA 3.5mm Lateral Proximal Tibia Plate, 4 Hole, Left

GUDID 07640187461978

Bonebridge AG

Orthopaedic fixation plate, non-bioabsorbable, sterile
Primary Device ID07640187461978
NIH Device Record Keya287d136-6767-4fee-9b39-e60208746a02
Commercial Distribution StatusIn Commercial Distribution
Brand NamePOYA 3.5mm Lateral Proximal Tibia Plate, 4 Hole, Left
Version Model NumberB-231100
Company DUNS480244832
Company NameBonebridge AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107640187461978 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-14
Device Publish Date2023-08-04

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