DTC

Basic Information

• Brand Name: DTC
• Primary DI: 06973554430422
• Version / Model: A333
• Company Name: Hangzhou DTC Medical Apparatus Co., Ltd.
• Labeler DUNS: 525905364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-06
• Public Version: 2
• Public Version Date: 2023-05-08
• Public Version Status: Update
• Public Device Record Key: 03f9b878-ca08-4c7c-9409-22478db0b5f6

Device Description

Universal lingual retainer

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35439	Orthodontic clasp, metal, preformed	A prefabricated dental device made of wrought metal alloy intended to retain and stabilize a removable orthodontic appliance to stationary teeth. It is manufactured to meet a standard specification for adaptation or direct insertion into the patient's mouth. This is a single-patient device that is 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
Primary	06973554430422	GS1