GUIDOR C11-008
GUDID 17640164360116
Bone grafting material, synthetic
SUNSTAR AMERICAS, INC.
Dental bone matrix implant, synthetic| Primary Device ID | 17640164360116 |
| NIH Device Record Key | 4e453f88-85cc-442a-9f20-d3f2e77f47c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GUIDOR |
| Version Model Number | easy-graft CLASSIC |
| Catalog Number | C11-008 |
| Company DUNS | 025066358 |
| Company Name | SUNSTAR AMERICAS, INC. |
| 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 | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx | |
| Phone | 8002658353 |
| xx@xx.xx |
Device Dimensions
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640164360072 [Primary] |
| GS1 | 17640164360116 [Package] Contains: 07640164360072 Package: Box [3 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K131385
FDA Product Code
| LYC | Bone Grafting Material, Synthetic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-22 |
On-Brand Devices [GUIDOR]
| 00070942000079 | GUIDOR® Bioresorbable Matrix Barrier |
| 00070942000062 | GUIDOR® Bioresorbable Matrix Barrier |
| 00070942000055 | GUIDOR® Bioresorbable Matrix Barrier |
| 00070942000048 | GUIDOR® Bioresorbable Matrix Barrier |
| 00070942000031 | GUIDOR® Bioresorbable Matrix Barrier |
| 00070942000017 | GUIDOR® Bioresorbable Matrix Barrier |
| 07640164360140 | Bone grafting material, synthetic |
| 17640164360130 | Bone grafting material, synthetic |
| 17640164360123 | Bone grafting material, synthetic |
| 17640164360116 | Bone grafting material, synthetic |
Trademark Results [GUIDOR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GUIDOR 78981212 3700450 Live/Registered |
Sunstar Suisse SA 2004-05-17 |
 GUIDOR 78419775 4020240 Live/Registered |
Sunstar Suisse SA 2004-05-17 |
 GUIDOR 77808345 not registered Dead/Abandoned |
Sunstar Suisse SA 2009-08-19 |
 GUIDOR 76441256 not registered Dead/Abandoned |
SUNSTAR LAUSANNE SA 2002-08-19 |
 GUIDOR 74021564 1686212 Dead/Cancelled |
Procordia OraTech AB 1990-01-23 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.