Primary Device ID | H980SC40001901S0 |
NIH Device Record Key | 4302dcfb-e29b-43c9-9c13-5f57e4da6054 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SyntheCel |
Version Model Number | SC.400.019.01S |
Catalog Number | SC40001901S |
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 |
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 |
Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radio- active sources |
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 |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 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 |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 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 |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 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 |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 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 |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 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 |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 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 |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 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 |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 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 |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 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 |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 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 |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 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 |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 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 |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 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 |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 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 |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10887587001364 [Primary] |
HIBCC | H980SC40001901S0 [Secondary] |
GXQ | DURA SUBSTITUTE |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-12-06 |
Device Publish Date | 2015-09-14 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SYNTHECEL 77722813 3701709 Live/Registered |
DEPUY SYNTHES, INC. 2009-04-27 |