OrthoSolutions 'System26' Bone Screws OS310012-NS

GUDID 05055662956719

2.0MM X 12MM TWIST OFF SCREW

ORTHO SOLUTIONS HOLDINGS LIMITED

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID05055662956719
NIH Device Record Key52810bc5-c2b1-4aa6-976c-88af5f2a09ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthoSolutions 'System26' Bone Screws
Version Model NumberOS310012-NS
Catalog NumberOS310012-NS
Company DUNS218648211
Company NameORTHO SOLUTIONS HOLDINGS LIMITED
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105055662956719 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05055662956719]

Moist Heat or Steam Sterilization


[05055662956719]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-16