OrthoSolutions 'System26' Bone Screws OS900048-NS

GUDID 05055662956214

COUNTERSINK FOR 4.0MM HEADLESS SCREW CANNULATED AO QC

ORTHO SOLUTIONS HOLDINGS LIMITED

Surgical countersink, reusable
Primary Device ID05055662956214
NIH Device Record Keye4e18981-8295-4f18-8ad6-41a3a9fb41e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthoSolutions 'System26' Bone Screws
Version Model NumberOS900048-NS
Catalog NumberOS900048-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
GS105055662956214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWWCountersink

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05055662956214]

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