Vitoss BA 2102-1500

GUDID 00808232000450

Bioactive Bone Graft Substitute, Foam Strip; Beta-Tricalcium Phosphate, Type I Bovine Collagen, and Bioactive Glass

Stryker Corporation

Bone matrix implant, composite
Primary Device ID00808232000450
NIH Device Record Keyd9c77d68-37a7-4528-9037-cc613c8e7728
Commercial Distribution StatusIn Commercial Distribution
Brand NameVitoss BA
Version Model Number2102-1500
Catalog Number2102-1500
Company DUNS149183167
Company NameStryker Corporation
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(610)640-1775
Emailspacustserv@stryker.com
Phone+1(610)640-1775
Emailspacustserv@stryker.com
Phone+1(610)640-1775
Emailspacustserv@stryker.com
Phone+1(610)640-1775
Emailspacustserv@stryker.com
Phone+1(610)640-1775
Emailspacustserv@stryker.com
Phone+1(610)640-1775
Emailspacustserv@stryker.com
Phone+1(610)640-1775
Emailspacustserv@stryker.com
Phone+1(610)640-1775
Emailspacustserv@stryker.com
Phone+1(610)640-1775
Emailspacustserv@stryker.com
Phone+1(610)640-1775
Emailspacustserv@stryker.com
Phone+1(610)640-1775
Emailspacustserv@stryker.com
Phone+1(610)640-1775
Emailspacustserv@stryker.com
Phone+1(610)640-1775
Emailspacustserv@stryker.com
Phone+1(610)640-1775
Emailspacustserv@stryker.com
Phone+1(610)640-1775
Emailspacustserv@stryker.com
Phone+1(610)640-1775
Emailspacustserv@stryker.com
Phone+1(610)640-1775
Emailspacustserv@stryker.com

Device Dimensions

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
Device Size Text, specify0
Length100 Millimeter
Width25 Millimeter
Height4 Millimeter
Device Size Text, specify0
Length100 Millimeter
Width25 Millimeter
Height4 Millimeter
Device Size Text, specify0
Length100 Millimeter
Width25 Millimeter
Height4 Millimeter
Device Size Text, specify0
Length100 Millimeter
Width25 Millimeter
Height4 Millimeter
Device Size Text, specify0
Length100 Millimeter
Width25 Millimeter
Height4 Millimeter
Device Size Text, specify0
Length100 Millimeter
Width25 Millimeter
Height4 Millimeter
Device Size Text, specify0
Length100 Millimeter
Width25 Millimeter
Height4 Millimeter
Device Size Text, specify0
Length100 Millimeter
Width25 Millimeter
Height4 Millimeter
Device Size Text, specify0
Length100 Millimeter
Width25 Millimeter
Height4 Millimeter
Device Size Text, specify0
Length100 Millimeter
Width25 Millimeter
Height4 Millimeter
Device Size Text, specify0
Length100 Millimeter
Width25 Millimeter
Height4 Millimeter
Device Size Text, specify0
Length100 Millimeter
Width25 Millimeter
Height4 Millimeter
Device Size Text, specify0
Length100 Millimeter
Width25 Millimeter
Height4 Millimeter
Device Size Text, specify0
Length100 Millimeter
Width25 Millimeter
Height4 Millimeter
Device Size Text, specify0
Length100 Millimeter
Width25 Millimeter
Height4 Millimeter
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Expose to Extreme Heat
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Expose to Extreme Heat
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Expose to Extreme Heat
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Expose to Extreme Heat
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Expose to Extreme Heat
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Expose to Extreme Heat
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Expose to Extreme Heat
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Expose to Extreme Heat
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Expose to Extreme Heat
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Expose to Extreme Heat
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Expose to Extreme Heat
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Expose to Extreme Heat
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Expose to Extreme Heat
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Expose to Extreme Heat
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Expose to Extreme Heat
Special Storage Condition, SpecifyBetween 0 and 0 *Ambient

Device Identifiers

Device Issuing AgencyDevice ID
GS100808232000450 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [Vitoss BA]

00808232000528Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, a
00808232000511Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, a
00808232000504Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, a
00808232000498Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, a
00808232000481Bioactive Bone Graft Substitute, Foam Strip; Beta-Tricalcium Phosphate, Type I Bovine Collagen,
00808232000474Bioactive Bone Graft Substitute, Foam Strip; Beta-Tricalcium Phosphate, Type I Bovine Collagen,
00808232000467Bioactive Bone Graft Substitute, Foam Strip; Beta-Tricalcium Phosphate, Type I Bovine Collagen,
00808232000450Bioactive Bone Graft Substitute, Foam Strip; Beta-Tricalcium Phosphate, Type I Bovine Collagen,

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