BoneSync BioActive ABS-3500-10

GUDID 00813954025568

Matrix Strip

COLLAGEN MATRIX, INC.

Bone matrix implant, animal-derived, bioabsorbable
Primary Device ID00813954025568
NIH Device Record Keyf410de9a-b963-4b04-93c3-bff747f25c3a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBoneSync BioActive
Version Model NumberABS-3500-10
Catalog NumberABS-3500-10
Company DUNS176262442
Company NameCOLLAGEN MATRIX, INC.
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

Phone239-598-4302
EmailCustomer_Service@Arthrex.com
Phone239-598-4302
EmailCustomer_Service@Arthrex.com
Phone239-598-4302
EmailCustomer_Service@Arthrex.com
Phone239-598-4302
EmailCustomer_Service@Arthrex.com
Phone239-598-4302
EmailCustomer_Service@Arthrex.com
Phone239-598-4302
EmailCustomer_Service@Arthrex.com
Phone239-598-4302
EmailCustomer_Service@Arthrex.com
Phone239-598-4302
EmailCustomer_Service@Arthrex.com
Phone239-598-4302
EmailCustomer_Service@Arthrex.com
Phone239-598-4302
EmailCustomer_Service@Arthrex.com
Phone239-598-4302
EmailCustomer_Service@Arthrex.com
Phone239-598-4302
EmailCustomer_Service@Arthrex.com
Phone239-598-4302
EmailCustomer_Service@Arthrex.com
Phone239-598-4302
EmailCustomer_Service@Arthrex.com
Phone239-598-4302
EmailCustomer_Service@Arthrex.com
Phone239-598-4302
EmailCustomer_Service@Arthrex.com
Phone239-598-4302
EmailCustomer_Service@Arthrex.com

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100813954025568 [Primary]

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 Date2023-03-16
Device Publish Date2023-03-08

On-Brand Devices [BoneSync BioActive]

00813954025032Matrix Putty
00813954025025Matrix Putty
00813954025018Matrix Putty
00813954025001Matrix Putty
00813954024998Matrix Strip
00813954024981Matrix Strip
00813954024974Matrix Strip
00813954024967Matrix Strip
00813954025438Matrix Putty
00813954025582Matrix Strip
00813954025575Matrix Strip
00813954025568Matrix Strip
00813954025551Matrix Strip
00813954025445Matrix Putty
00813954025421Matrix Putty
00813954025414Matrix Putty

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