Primary Device ID | D8130307550000 |
NIH Device Record Key | 90190783-bae6-48be-9977-d54055e38232 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Dry-Bond |
Version Model Number | 030755000 |
Catalog Number | 030755000 |
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 | true |
Expiration Date | false |
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 |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not expose to source of ignition or open flame |
Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D8130307550000 [Primary] |
KZP | Solution, Cement Disolving |
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 |
D81375500 | DRY-BOND 25mL |
D81375250 | COMP SOLVENT/SURFACE COND 25mL |
D81375000 | DRY-BOND 240mL |
D8130307550000 | DRY-BOND 10mL W/INST |