Osteo Screw Washer

GUDID 00840118106603

implant for orthopedic bone fixation, compatible with 3.5mm/4.0mm/4.5mm screws

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic bone washer, sterile
Primary Device ID00840118106603
NIH Device Record Keyfed6579b-d5fd-4a74-b62a-8613b140b5ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteo Screw Washer
Version Model NumberOSW 100
Company DUNS078790947
Company NameFLOWER ORTHOPEDICS CORPORATION
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840118106603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTNWasher, Bolt Nut

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 Date2015-09-22

On-Brand Devices [Osteo Screw Washer]

00840118106610implant for orthopedic bone fixation, compatible with 5.5mm/6.5mm/7.3mm screws
00840118106603implant for orthopedic bone fixation, compatible with 3.5mm/4.0mm/4.5mm screws

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