Vitoss BA 2102-1602

GUDID 00808232000504

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

Stryker Corporation

Bone matrix implant, composite
Primary Device ID00808232000504
NIH Device Record Keyb440ce90-2a97-4c67-8894-f296fb1b13f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameVitoss BA
Version Model Number2102-1602
Catalog Number2102-1602
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
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

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Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100808232000504 [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 Number2
Public Version Date2018-03-29
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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