OrthoSolutions 'System26' Bone Screws OS900065B-NS

GUDID 05055662918397

K-WIRE GUIDE INSERT FOR 6.5MM SCREW

ORTHO SOLUTIONS HOLDINGS LIMITED

Orthopaedic implant aiming/guiding block, reusable
Primary Device ID05055662918397
NIH Device Record Key326b2cf4-47f2-4223-9a4b-d5051354b181
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthoSolutions 'System26' Bone Screws
Version Model NumberOS900065B-NS
Catalog NumberOS900065B-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
GS105055662918397 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05055662918397]

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