Biomet SpinalPak / OrthoPak 1067724-2

GUDID 00812301020300

20" LEAD WIRES, REPLACEMENT

EBI, LLC

Patient-worn bone growth electromagnetic stimulator
Primary Device ID00812301020300
NIH Device Record Keydea071ef-d19a-4fc9-b630-4cf58e0b1cbf
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiomet SpinalPak / OrthoPak
Version Model Number1067724-2
Catalog Number1067724-2
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
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
Phone1.973.299.9300
EmailBTBS.CSORDERS@BIOMET.COM
Phone1.973.299.9300
EmailBTBS.CSORDERS@BIOMET.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100812301020300 [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

On-Brand Devices [Biomet SpinalPak / OrthoPak]

00812301020393AC ADAPTOR, ALTERNATE
00812301020386AC ADAPTER KIT
00812301020379WALL PLUG ADAPTER KIT
00812301020362AC ADAPTOR, REPLACEMENT
0081230102033172" LEAD WIRES, REPLACEMENT
0081230102032448" LEAD WIRES, REPLACEMENT
0081230102031730" LEAD WIRES, REPLACEMENT
0081230102030020" LEAD WIRES, REPLACEMENT
0081230102029412" LEAD WIRES, REPLACEMENT
00812301020287EXTREMITY BAND, REPLACEMENT
00812301020270STIMULATOR HOLSTER, REPLACEMENT
00812301020263BATTERY PACK CHARGER, REPLACEMENT
00812301020256BATTERY PACK, REPLACEMENT
00812301020201ELECTRODES 72R, SOFT TOUCH REPLACEMENT
00812301020195ELECTRODE COVER PATCHES
00812301020188ELECTRODES, LT-4500
00880304820852ELECTRODES, 63B, SPINALPAK/ORTHOPAK
00880304820845BELT EXTENSION, LARGE, SPINALPAK
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