ROEKO Retracto

Basic Information

• Brand Name: ROEKO Retracto
• Primary DI: E1655110000
• Version / Model: 511000
• Catalog Number: 511000
• Company Name: Coltène/Whaledent GmbH + Co. KG
• Labeler DUNS: 315494443
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-22
• Public Version: 1
• Public Version Date: 2022-09-30
• Public Version Status: New
• Public Device Record Key: ed8428ad-a3fb-4677-8f9b-ddd333ff306f

Device Description

ROEKO Retracto Braided non-impregnated size 0 (x-fine)

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	E1655110000	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K041023	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: keep dry