Re-Cord™ Knitted Retraction Cord #3

Basic Information

• Brand Name: Re-Cord™ Knitted Retraction Cord #3
• Primary DI: 00359883005740
• Version / Model: 649106
• Catalog Number: 649106
• Company Name: DEN-MAT HOLDINGS, LLC
• Labeler DUNS: 809857704
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-12
• Public Version: 1
• Public Version Date: 2025-03-20
• Public Version Status: New
• Public Device Record Key: 68152911-fea4-43a2-8d84-3e9fe73340e4

Device Description

Gingival retraction cord, non-medicated

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JES	FLOSS, DENTAL	Dental	872.6390	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46037	Gingival retraction cord, medicated	A medicated (e.g., with epinephrine) cotton string intended to be used to temporarily push gum tissue (gingiva) away from prepared tooth margins to help make an accurate dental impression. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00359883005740	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	244	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from heat, sparks and flame.
• Type: Handling Environment Temperature
• Temperature Range: High: 25 Degrees Celsius