MucoHard™ S485
GUDID 00810000525256
MucoHard™ Bonding Liner with 6-Brushes & 6-Pipettes
PARKELL, INC.
Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard Denture reliner, hard| Primary Device ID | 00810000525256 |
| NIH Device Record Key | 86454098-d150-45e2-8175-af37c648153b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MucoHard™ |
| Version Model Number | S485 |
| Catalog Number | S485 |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000525256 [Primary] |
FDA Product Code
| EBI | Resin, Denture, Relining, Repairing, Rebasing |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-09-20 |
| Device Publish Date | 2018-10-26 |
On-Brand Devices [MucoHard™]
| 00810000525270 | MucoHard™ Hard Denture Reline Kit |
| 00810000525263 | MucoHard™ Resin Refill Cartridge with Tips |
| 00810000525256 | MucoHard™ Bonding Liner with 6-Brushes & 6-Pipettes |
| M595S4870 | MucoHard™ Hard Denture Reline Kit |
| M595S4860 | MucoHard™ Resin Refill Cartridge with Tips |
| M595S4850 | MucoHard™ Bonding Liner with 6-Brushes & 6-Pipettes |
| 00810000525690 | MucoHard™+ Primer Refill |
| 00810000525683 | MucoHard™+ Cartridge Refill |
| 00810000525676 | MucoHard™+ Kit |
Trademark Results [MucoHard]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MUCOHARD 87217630 5214032 Live/Registered |
Parkell, Inc. 2016-10-27 |
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