Biomet OrthoPak Non-invasive Stimulator 1067783-1

GUDID 00812301020409

BATTERY DOOR, BIOMET ORTHOPAK REPLACEMENT

EBI, LLC

Patient-worn bone growth electromagnetic stimulator
Primary Device ID00812301020409
NIH Device Record Keybb8c965d-b750-454d-a961-07481a366854
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiomet OrthoPak Non-invasive Stimulator
Version Model Number1067783-1
Catalog Number1067783-1
Company DUNS050410323
Company NameEBI, LLC
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com
Phone1.973.299.9300
Emailbtbs.csorders@biomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100812301020409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOFStimulator, Bone Growth, Non-Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-19

Devices Manufactured by EBI, LLC

00887868269264 - Biomet SpinalPak Non-invasive Spine Fusion Stimulator System2019-03-11
00887868269271 - Biomet SpinalPak Non-invasive Spine Fusion Stimulator System2019-03-11
00887868269288 - Biomet SpinalPak Non-invasive Spine Fusion Stimulator System2019-03-11
00887868269295 - Biomet OrthoPak Non-invasive Bone Growth Stimulator System2019-03-11
00887868269301 - Biomet OrthoPak Non-invasive Bone Growth Stimulator System2019-03-11
00887868269318 - Biomet OrthoPak Non-invasive Bone Growth Stimulator System2019-03-11
00880304820845 - Biomet SpinalPak / OrthoPak2018-07-06 BELT EXTENSION, LARGE, SPINALPAK
00880304820852 - Biomet SpinalPak / OrthoPak2018-07-06 ELECTRODES, 63B, SPINALPAK/ORTHOPAK

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