Dryz™ S180

GUDID 10810000525086

Dryz™ Syringe Gingival Hemostatic Retraction Paste (Pkg. of 7 Syringes)

PARKELL, INC.

Gingival retraction cord, non-medicated

• Primary Device ID: 10810000525086
• NIH Device Record Key: 43fe5f0e-e016-4ce4-b805-a26c005cb81d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dryz™
• Version Model Number: S180
• Catalog Number: S180
• Company DUNS: 009900424
• Company Name: PARKELL, INC.
• Device Count: 7
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing. Avoid sunlight or nearby heat sources.
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing. Avoid sunlight or nearby heat sources.
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing. Avoid sunlight or nearby heat sources.
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing. Avoid sunlight or nearby heat sources.
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing. Avoid sunlight or nearby heat sources.
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing. Avoid sunlight or nearby heat sources.
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing. Avoid sunlight or nearby heat sources.
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing. Avoid sunlight or nearby heat sources.
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing. Avoid sunlight or nearby heat sources.
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing. Avoid sunlight or nearby heat sources.
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing. Avoid sunlight or nearby heat sources.
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing. Avoid sunlight or nearby heat sources.
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing. Avoid sunlight or nearby heat sources.
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing. Avoid sunlight or nearby heat sources.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000525089 [Unit of Use]
GS1	10810000525086 [Primary]

FDA Product Code

• MVL: Cord, Retraction

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: 2024-04-03
• Device Publish Date: 2018-09-21

On-Brand Devices [Dryz™]

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• 00810000525089: Dryz™ Syringe Gingival Retraction Paste Sample (Contains; 1- Syringe & 2-Tips)
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• 20810000525168: Dryz Blu Syringe Gingival Retraction Paste Value Pack (Pkg. of 25 Syringes)
• 20810000525144: Dryz™ BLU Unit-Dose Gingival Retraction Paste Sample (Contains; 3-Capsules)
• 20810000525106: Dryz™ Unit-Dose Gingival Retaction Paste Sample (Contains; 3-Capsules)
• 20810000525083: Dryz™ Syringe Gingival Retraction Paste Value Pack (Pkg. of 25 Syringes)
• 10810000525161: Dryz™ Blu Syringe Gingival Retraction Paste (Pkg. of 7 Syringes)
• 10810000525147: Dryz™ BLU Unit-Dose Gingival Retraction Paste (Pkg. of 30 Capsules)
• 10810000525109: Dryz™ Unit-Dose Gingival Retraction Paste (Pkg. of 30 Capsules)
• 00810000525119: Dryz™ Syringe Gingival Retraction Paste Sample (Contains; 1- Syringe & 2-Tips)
• 00810000525386: DryZ® Blu Syringe Gingival Retraction Paste Sample (Contains; 1- Syringe & 2-Tips)
• 00810000525577: Dryz™ Syringe Gingival Hemostatic Retraction Paste (Pkg. of 7 Syringes) for Korea
• 00810000526802: Dryz™ Syringe Luer-Lock Applicator Tips (Pkg. of 40 pcs.)
• 10810000526809: Dryz™ Syringe Luer-Lock Applicator Tips (Pkg. of 40 pcs.)
• 00810000525355: DryZ® Syringe Gingival Retraction Paste Sample (Contains; 1- Syringe & 2-Tips) with Japanese I
• 10810000525086: Dryz™ Syringe Gingival Hemostatic Retraction Paste (Pkg. of 7 Syringes)