Cortical Screw ø3.5mm L75mm

GUDID 07640187461213

Bonebridge AG

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID07640187461213
NIH Device Record Key5b843cd4-b829-48a1-9190-6f574955687c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCortical Screw ø3.5mm L75mm
Version Model NumberB-324075
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 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
GS107640187461213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640187461213]

Moist Heat or Steam Sterilization


[07640187461213]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-01-13
Device Publish Date2022-12-23

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