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 Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite 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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