Biomet SpinalPak Non-invasive Spine Fusion Stimulator System 1067725

GUDID 00812301020348

SPINALPAK ASSEMBLY - ROW

EBI, LLC

Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator
Primary Device ID00812301020348
NIH Device Record Key2fa709e9-aeac-4d72-bf17-1a9e8ebe9417
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiomet SpinalPak Non-invasive Spine Fusion Stimulator System
Version Model Number1067725
Catalog Number1067725
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 Batchfalse
Serial Numbertrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 100 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 100 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 100 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 100 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 100 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 100 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 100 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 100 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 100 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 100 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 100 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 100 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 100 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100812301020348 [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 Non-invasive Spine Fusion Stimulator System]

00812301020416BATTERY DOOR, BIOMET SPINALPAK REPLACEMENT
00812301020348SPINALPAK ASSEMBLY - ROW
00812301020225SPINALPAK STIMULATOR, BIOMET
00812301020218SPINALPAK ASSEMBLY
008878682692881067716-72
008878682692711067716-63
008878682692641067716-45

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.