ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS OS361009

GUDID 05055662929294

MEMO STAPLE UNIVERSAL SPREADER

ORTHO SOLUTIONS HOLDINGS LIMITED

Orthopaedic implant inserter/extractor, reusable
Primary Device ID05055662929294
NIH Device Record Keyf0ed6553-4832-47c4-aaf0-1fb11932cb95
Commercial Distribution StatusIn Commercial Distribution
Brand NameORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS
Version Model NumberOS361009
Catalog NumberOS361009
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
GS105055662929294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05055662929294]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-23
Device Publish Date2016-05-16

On-Brand Devices [ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS]

05055662929355EFS DRILL GUIDE 2.4MM/3.0MM SCREW
05055662929348EFS DRILL GUIDE 1.2MM/2.0MM SCREW
05055662929317COMPRESSION STAPLE DRILL GUIDE 2.7MM
05055662929294MEMO STAPLE UNIVERSAL SPREADER
05055662929287MEMO STAPLE 20MM & 25MM & 16MM EXPANDER
05055662929270MEMO STAPLE 10MM & 12MM EXPANDER
05055662928921FOS DRILL GUIDE
05055662923780FPS 2.7MM DRILL GUIDE SHORT

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