Primary Device ID | D8130314585500 |
NIH Device Record Key | f20d6867-c12c-4089-8715-fa08cb71ee38 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Geristore® |
Version Model Number | 031458550 |
Catalog Number | 031458550 |
Company DUNS | 809857704 |
Company Name | DEN-MAT HOLDINGS, LLC |
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 | false |
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 | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Refrigerate for maximum shelf-life |
Special Storage Condition, Specify | Between 0 and 0 *Return to room temperature prior to use |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D8130314585500 [Primary] |
EMA | Cement, Dental |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-24 |
D81345060 | GERISTORE A S/S 10g |
D813034526101B0 | GERISTORE PST B SH A3.5 10g |
D8130345241010 | GERISTORE PST B SH A3 10g |
D8130345231010 | GERISTORE PST B SH A2 10g |
D8130345221010 | GERISTORE PST B SH A1 10g |
D8130314793000 | HOLISTORE A AND B JARS |
D8130314771000 | GERISTORE VALUE CUSTOM KIT |
D8130314761100 | GERISTORE A2 SY INTRO KIT |
D8130314585500 | GERISTORE VALUE SY KIT A2 |
D8130314577300 | GERISTORE SY KIT A3.5 |
D8130314577200 | GERISTORE SY KIT A3 |
D8130314575200 | GERISTORE VALUE SY KIT A3 |
D8130314575000 | GERISTORE SY KIT A2 |
D8130304511100 | BIO-CAP KIT |
D813030450911B0 | GERISTORE A S/S 10g |
D8130398457300 | GERISTOR SY SMP A2 BAG 1FLW IT |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GERISTORE 74194248 1706205 Live/Registered |
DEN-MAT HOLDINGS, LLC 1991-08-13 |