Actifuse ABX 506005078051

GUDID 05060050780517

Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 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

Primary Device ID	05060050780517
NIH Device Record Key	5ee905c1-a000-42e0-801c-e481c621e9bf
Commercial Distribution Status	In Commercial Distribution
Brand Name	Actifuse ABX
Version Model Number	506005078051
Catalog Number	506005078051
Company DUNS	221517829
Company Name	Apatech Ltd
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter
Total Volume	5 Milliliter

Operating and Storage Conditions

Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060050780517 [Primary]

FDA Product Code

LYC	Bone grafting material, synthetic

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2015-09-24

On-Brand Devices [Actifuse ABX]

05060050780609	Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 1.5ml pack size
05060050780586	Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 20ml pack size
05060050780524	Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 10ml pack size
05060050780517	Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 5ml pack size
05060050780500	Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 2.5ml pack size