Actifuse E-Z-Prep 506005078054

GUDID 05060050780548

Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 10ml pack size

Apatech Ltd

Bone matrix implant, synthetic
Primary Device ID05060050780548
NIH Device Record Key9f7f8e0b-5b9b-4c41-8f77-18e21ad55cbe
Commercial Distribution StatusIn Commercial Distribution
Brand NameActifuse E-Z-Prep
Version Model Number506005078054
Catalog Number506005078054
Company DUNS221517829
Company NameApatech Ltd
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

Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com

Device Dimensions

Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS105060050780548 [Primary]

FDA Product Code

MQVFILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-09-24

Devices Manufactured by Apatech Ltd

00085412630731 - ALTAPORE2022-06-02 Bioactive and Osteoconductive - Silicate Substituted Calcium Phosphate bone void filler
00085412678146 - ALTAPORE2021-01-05 Bioactive and Osteoconductive - Silicate Substituted Calcium Phosphate bone void filler
05413760478975 - ALTAPORE2020-05-12 Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate
05413760478968 - ALTAPORE2020-05-05 Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate
05413760478982 - ALTAPORE2020-05-05 Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate
05413760478999 - ALTAPORE2020-05-05 Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate
05413760479002 - ALTAPORE2020-05-05 Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate
00085412654362 - ALTAPORE2019-12-19 Bioactive Bone Graft Substitute - Silicate Substituted Calcium Phosphate

Trademark Results [Actifuse E-Z-Prep]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACTIFUSE E-Z-PREP
ACTIFUSE E-Z-PREP
77039232 3580994 Dead/Cancelled
ApaTech Limited
2006-11-08

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