Actifuse MIS 506005078070

GUDID 05060050780708

Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 7.5ml pack size

Apatech Ltd

Bone matrix implant, synthetic Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial
Primary Device ID05060050780708
NIH Device Record Keyc11212ea-d2a0-416e-893b-f833139af9b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameActifuse MIS
Version Model Number506005078070
Catalog Number506005078070
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
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 Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter
Total Volume7.5 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060050780708 [Primary]

FDA Product Code

LYCBone grafting material, synthetic

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

On-Brand Devices [Actifuse MIS]

05060050780722Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 7.5ml pack size
05060050780708Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 7.5ml pack size
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.