OrthoSolutions 'System26' Bone Screws OS900021-NS

GUDID 05055662948493

AXIAL HANDLE RATCHETING CANNULATED JACOBS QC

ORTHO SOLUTIONS HOLDINGS LIMITED

Surgical instrument handle, non-torque-limiting
Primary Device ID05055662948493
NIH Device Record Key472cd51d-5c12-44c1-b5be-26f4f66354cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthoSolutions 'System26' Bone Screws
Version Model NumberOS900021-NS
Catalog NumberOS900021-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 Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105055662948493 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05055662948493]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-09
Device Publish Date2017-03-16