OTC S827

GUDID 00810000525591

OTC Primer in 4-Litre Bottles

PARKELL, INC.

Denture reliner, soft, professional

• Primary Device ID: 00810000525591
• NIH Device Record Key: 0d777210-6050-4a31-8225-2a687ac4b6e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTC
• Version Model Number: S827
• Catalog Number: S827
• 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: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com
• Phone: 631-249-1134
• Email: customerservice@parkell.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing. Avoid storing near excessive heat or direct sunlight light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing. Avoid storing near excessive heat or direct sunlight light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing. Avoid storing near excessive heat or direct sunlight light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing. Avoid storing near excessive heat or direct sunlight light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing. Avoid storing near excessive heat or direct sunlight light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing. Avoid storing near excessive heat or direct sunlight light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing. Avoid storing near excessive heat or direct sunlight light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing. Avoid storing near excessive heat or direct sunlight light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing. Avoid storing near excessive heat or direct sunlight light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing. Avoid storing near excessive heat or direct sunlight light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing. Avoid storing near excessive heat or direct sunlight light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing. Avoid storing near excessive heat or direct sunlight light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing. Avoid storing near excessive heat or direct sunlight light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing. Avoid storing near excessive heat or direct sunlight light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing. Avoid storing near excessive heat or direct sunlight light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid freezing. Avoid storing near excessive heat or direct sunlight light.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000525591 [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: 2021-06-21
• Device Publish Date: 2021-06-11

On-Brand Devices [OTC]

• 00810000525591: OTC Primer in 4-Litre Bottles
• 00810000525744: OTC Remover in 4 Liter Bottle