Vitoss BBTrauma 2102-2210
GUDID 00808232001341
Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, and Bioactive Glass
Stryker Corporation
Bone matrix implant, composite| Primary Device ID | 00808232001341 |
| NIH Device Record Key | 6a9f4592-9af6-41f0-9b04-8d7527e2f679 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vitoss BBTrauma |
| Version Model Number | 2102-2210 |
| Catalog Number | 2102-2210 |
| Company DUNS | 149183167 |
| Company Name | Stryker Corporation |
| 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(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx | |
| Phone | +1(610)640-1775 |
| xxx@xxx.xxx |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Expose to Extreme Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00808232001341 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103173
FDA Product Code
| MQV | FILLER, BONE VOID, CALCIUM COMPOUND |
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 [Vitoss BBTrauma]
| 00808232001341 | Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, a |
| 00808232001334 | Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, a |
| 00808232001327 | Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, a |
| 00808232001310 | Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, a |
Trademark Results [Vitoss BBTrauma]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VITOSS BBTRAUMA 85623081 4411816 Live/Registered |
Orthovita, Inc. 2012-05-11 |
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