Primary Device ID | H9806160301S0 |
NIH Device Record Key | 6e17f5c4-3b85-439c-8d6f-91eac128933a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CRANIOS Reinforced |
Version Model Number | 616.03.01S |
Catalog Number | 6160301S |
Company DUNS | 832637081 |
Company Name | SYNTHES (U.S.A.) LP |
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 |
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 | |
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 |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10887587058672 [Primary] |
HIBCC | H9806160301S0 [Secondary] |
GXP | METHYL METHACRYLATE FOR CRANIOPLASTY |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2015-09-14 |
H9806161001S0 | CRANIOS REINFORCED ROTARY MIX 10CC-STERILE |
H9806160501S0 | CRANIOS REINFORCED ROTARY MIX 5CC-STERILE |
H9806160301S0 | CRANIOS REINFORCED ROTARY MIX 3CC-STERILE |
H9806151001S0 | CRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE |
H9806150501S0 | CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE |
H9806150301S0 | CRANIOS REINFORCED FAST SET PUTTY 3CC-STERILE |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CRANIOS REINFORCED 85186089 4250595 Live/Registered |
DEPUY SYNTHES, INC. 2010-11-29 |