SyntheCel SC40028001S
GUDID 10887587076669
SYNTHECEL® DURA REPAIR 14CM X 20CM (5.5"X 8") STER
SYNTHES (U.S.A.) LP
Dura mater graft, bioengineered Dura mater graft, bioengineered Dura mater graft, bioengineered Dura mater graft, bioengineered Dura mater graft, bioengineered Dura mater graft, bioengineered Dura mater graft, bioengineered Dura mater graft, bioengineered Dura mater graft, bioengineered Dura mater graft, bioengineered Dura mater graft, bioengineered Dura mater graft, bioengineered Dura mater graft, bioengineered Dura mater graft, bioengineered Dura mater graft, bioengineered Dura mater graft, bioengineered Dura mater graft, bioengineered Dura mater graft, bioengineered Dura mater graft, bioengineered Dura mater graft, bioengineered Dura mater graft, bioengineered Dura mater graft, bioengineered| Primary Device ID | 10887587076669 |
| NIH Device Record Key | b937995e-bdcc-405f-a31c-4cc0358e960b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SyntheCel |
| Version Model Number | SC.400.280.01S |
| Catalog Number | SC40028001S |
| Company DUNS | 832637081 |
| Company Name | SYNTHES (U.S.A.) LP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Operating and Storage Conditions
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10887587076669 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K212943
FDA Product Code
| GXQ | DURA SUBSTITUTE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-03 |
| Device Publish Date | 2022-05-26 |
On-Brand Devices [SyntheCel]
| H980SC40012001S0 | SYNTHECEL® DURA REPAIR 10.0CM X 12.0CM(4" X5")STERILE |
| H980SC40005601S0 | SYNTHECEL® DURA REPAIR 7.5CM X 7.5CM(3" X 3")STERILE |
| H980SC40002501S0 | SYNTHECEL® DURA REPAIR 5.0CM X 5.0CM(2" X 2")STERILE |
| H980SC40001901S0 | SYNTHECEL® DURA REPAIR 2.5CM X 7.5CM(1" X 3")STERILE |
| H980SC40000601S0 | SYNTHECEL® DURA REPAIR 2.5CM X 2.5CM(1" X 1")STERILE |
| 10887587076669 | SYNTHECEL® DURA REPAIR 14CM X 20CM (5.5"X 8") STER |
Trademark Results [SyntheCel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYNTHECEL 77722813 3701709 Live/Registered |
DEPUY SYNTHES, INC. 2009-04-27 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.