Primary Device ID | 08806383556989 |
NIH Device Record Key | d45483ef-76e6-417e-8a93-b3aeab1dfb78 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DUO-PEN |
Version Model Number | DUO-PEN HEATING CONDENSOR(04-40) |
Catalog Number | 4007-2070 |
Company DUNS | 687789453 |
Company Name | DiaDent Group International |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
Serial Number | false |
Manufacturing Date | false |
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 |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08806383556989 [Primary] |
EKR | Plugger, Root Canal, Endodontic |
Steralize Prior To Use | true |
Device Is Sterile | true |
[08806383556989]
Moist Heat or Steam Sterilization
[08806383556989]
Moist Heat or Steam Sterilization
[08806383556989]
Moist Heat or Steam Sterilization
[08806383556989]
Moist Heat or Steam Sterilization
[08806383556989]
Moist Heat or Steam Sterilization
[08806383556989]
Moist Heat or Steam Sterilization
[08806383556989]
Moist Heat or Steam Sterilization
[08806383556989]
Moist Heat or Steam Sterilization
[08806383556989]
Moist Heat or Steam Sterilization
[08806383556989]
Moist Heat or Steam Sterilization
[08806383556989]
Moist Heat or Steam Sterilization
[08806383556989]
Moist Heat or Steam Sterilization
[08806383556989]
Moist Heat or Steam Sterilization
[08806383556989]
Moist Heat or Steam Sterilization
[08806383556989]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-06-03 |
Device Publish Date | 2020-05-26 |
08806383557351 | Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca |
08806383557344 | Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca |
08806383557337 | Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca |
08806383557320 | Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca |
08806383557108 | Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca |
08806383557023 | Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca |
08806383557016 | Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca |
08806383557009 | Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca |
08806383556996 | Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca |
08806383556989 | Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca |
08806383586320 | Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca |