Dryz™

Basic Information

• Brand Name: Dryz™
• Primary DI: 10810000525147
• Version / Model: S187
• Catalog Number: S187
• Company Name: PARKELL, INC.
• Labeler DUNS: 009900424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2018-09-21
• Public Version: 4
• Public Version Date: 2024-01-23
• Public Version Status: Update
• Public Device Record Key: 635e5bad-a75a-4ef2-b218-fcf16e0b9470

Device Description

Dryz™ BLU Unit-Dose Gingival Retraction Paste (Pkg. of 30 Capsules)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MVL	Cord, Retraction	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
35861	Gingival retraction cord, non-medicated	A non-medicated, cotton string used to temporarily hold off the gingiva during abutment preparation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10810000525147	GS1
Unit of Use	00810000525140	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing; bring to room temperature. Avoid sunlight or nearby heat sources.