ORTHO SOLUTIONS STERILE DRILL BITSORTHO SOLUTIONS OSS-8351

GUDID 05055662942262

SAGITTAL BLADE 90.0MM X 25.4MM X 1.20MM

ORTHO SOLUTIONS HOLDINGS LIMITED

Oscillating surgical saw blade, single-use
Primary Device ID05055662942262
NIH Device Record Key6104189a-243f-4764-b698-4131a2642031
Commercial Distribution StatusIn Commercial Distribution
Brand NameORTHO SOLUTIONS STERILE DRILL BITSORTHO SOLUTIONS
Version Model NumberOSS-8351
Catalog NumberOSS-8351
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 Datetrue
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
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105055662942262 [Package]
Contains: 05055662942279
Package: Cardboard Box [5 Units]
In Commercial Distribution
GS105055662942279 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-23

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05055662970104 - Volition™ Plating System2024-09-10 MTPJ PLATE EXTRA SHORT RIGHT
05055662970128 - Volition™ Plating System2024-09-10 TIBIA PLATE ANTERIOR LARGE LEFT
05055662970142 - Volition™ Plating System2024-09-10 TIBIA PLATE ANTERIOR LARGE RIGHT
05055662970166 - Volition™ Plating System2024-09-10 TIBIA PLATE ANTERIOR SMALL LEFT
05055662970180 - Volition™ Plating System2024-09-10 TIBIA PLATE ANTERIOR SMALL RIGHT
05055662969658 - COGNiTiON™ Staple System2024-04-09 COGNiTiON 2 LEG STAPLE 10MM X10MM
05055662969665 - COGNiTiON™ Staple System2024-04-09 COGNiTiON 2 LEG STAPLE 15MM X 15MM

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