Patient Transfer Kit

Basic Information

• Brand Name: Patient Transfer Kit
• Primary DI: 07540295000383
• Version / Model: 07540295000383
• Company Name: Hespeler Orthodontics Limited
• Labeler DUNS: 203297635
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-09
• Public Version: 1
• Public Version Date: 2024-08-19
• Public Version Status: New
• Public Device Record Key: 47fb9baa-497d-4490-aea5-4182afc42792

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• PM Exempt: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
46581	Orthodontic bracket, metal	A metallic device that is bonded to an orthodontic band, or directly 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
62086	Self-ligating orthodontic bracket open/close tool	A hand-held dental instrument intended to be used by an orthodontist for opening/closing a self-ligating orthodontic bracket and/or tube. It is made of metal and is in the form of a handle with thin pronged ends designed to release/close the orthodontic appliance clip mechanism; it may also be used to hold the archwire in place to assist manual closing of the clip. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540295000383	GS1
Previous	75402950800053	GS1