Actifuse Flow 506005078076

GUDID 55060050780765

Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 1.5ml 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
Primary Device ID55060050780765
NIH Device Record Keyac15aa0a-fcdc-435a-a6c2-5d790efe05a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameActifuse Flow
Version Model Number506005078076
Catalog Number506005078076
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

Device Dimensions

Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS105060050780760 [Primary]
GS155060050780765 [Package]
Contains: 05060050780760
Package: CASE [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-12
Device Publish Date2018-10-10

On-Brand Devices [Actifuse Flow]

55060050780789Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 5.0ml pack size
55060050780772Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 3.0ml pack size
55060050780765Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 1.5ml pack size
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