Retrieve™ S251-K

GUDID 00810000525621

Retrieve™ DC Non-Eugenol Resin-Based Implant Cement (Korea)

PARKELL, INC.

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• Primary Device ID: 00810000525621
• NIH Device Record Key: 16710838-e07c-4c07-9e34-9bac6c569ef2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Retrieve™
• Version Model Number: S251-K
• Catalog Number: S251-K
• 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
• 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
• 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
• 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 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring to room temperature before use.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring to room temperature before use.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring to room temperature before use.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring to room temperature before use.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring to room temperature before use.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring to room temperature before use.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring to room temperature before use.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring to room temperature before use.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring to room temperature before use.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring to room temperature before use.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring to room temperature before use.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring to room temperature before use.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring to room temperature before use.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring to room temperature before use.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring to room temperature before use.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring to room temperature before use.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring to room temperature before use.
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store tightly sealed in a cool, dark, low humidity environment. Refrigeration is acceptable, but do not freeze. Bring to room temperature before use.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000525621 [Primary]

FDA Product Code

• EMA: Cement, Dental

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: 2021-12-22
• Device Publish Date: 2021-12-10

On-Brand Devices [Retrieve™]

• M595S2500: Retrieve™ Non-Eugenol Resin-Based Implant Cement
• 00810000525324: Retrieve™ DC Non-Eugenol Resin-Based Implant Cement
• 00810000525621: Retrieve™ DC Non-Eugenol Resin-Based Implant Cement (Korea)
• 10810000526854: Mixing Tip with Brown Base for E.T.C.™ & Retrieve™ (Pkg. of 30 pcs.)