MucoHard™ S640

GUDID 00810000525676

MucoHard™+ Kit

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

• Primary Device ID: 00810000525676
• NIH Device Record Key: a35db6e2-d3dd-4a43-8ee6-0cb91001caeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MucoHard™
• Version Model Number: S640
• Catalog Number: S640
• 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

• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature with a clean cap tightly locked on. Avoid freezing. Do not store 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 at room temperature with a clean cap tightly locked on. Avoid freezing. Do not store 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 at room temperature with a clean cap tightly locked on. Avoid freezing. Do not store 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 at room temperature with a clean cap tightly locked on. Avoid freezing. Do not store 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 at room temperature with a clean cap tightly locked on. Avoid freezing. Do not store 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 at room temperature with a clean cap tightly locked on. Avoid freezing. Do not store 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 at room temperature with a clean cap tightly locked on. Avoid freezing. Do not store 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 at room temperature with a clean cap tightly locked on. Avoid freezing. Do not store near excessive heat, light, or fresh eugenol-containing materials.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000525676 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-04
• Device Publish Date: 2022-06-24

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