Bone Plug B001-0110

GUDID 04546540007896

Sized Cement Plug

Howmedica Osteonics Corp.

Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile
Primary Device ID04546540007896
NIH Device Record Key360e5ac3-7eea-4b12-86f6-477e3bd0f042
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Plug
Version Model NumberB001-0110
Catalog NumberB001-0110
Company DUNS058311945
Company NameHowmedica Osteonics Corp.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104546540007896 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LTOSPACER, CEMENT

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 Date2015-09-24

On-Brand Devices [Bone Plug]

07613327036695Canal -Cemented
07613327036671Canal -Cemented
07613327036664Canal -Cemented
07613153768371Sized Cement Plug
04546540007957Sized Cement Plug
04546540007940Sized Cement Plug
04546540007933Sized Cement Plug
04546540007926Sized Cement Plug
04546540007919Sized Cement Plug
04546540007902Sized Cement Plug
04546540007896Sized Cement Plug

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