N/A

Basic Information

• Brand Name: N/A
• Primary DI: 10195291008372
• Version / Model: RCMLL519-V
• Company Name: Flexmedics
• Labeler DUNS: 028853567
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2020-05-28
• Public Version: 2
• Public Version Date: 2023-07-26
• Public Version Status: Update
• Public Device Record Key: dafbbf2d-f29e-477e-9967-a4286ee453f6

Device Description

ROTH CMP LL5 HK 018, -22°T, 0°A 5PK

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: Yes
• 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
DYW	Bracket, Plastic, Orthodontic	Dental	872.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46582	Orthodontic bracket, plastic, single-use	A plastic device intended to be bonded to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00195291008375	GS1
Primary	10195291008372	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K973776	000