Magrain Gold with Tan Color Tape, without pack, with Latex

Basic Information

• Brand Name: Magrain Gold with Tan Color Tape, without pack, with Latex
• Primary DI: 04955114013124
• Version / Model: 8010011
• Company Name: SAKAMURA KENKYUSHO, K.K.
• Labeler DUNS: 703091116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-22
• Public Version: 1
• Public Version Date: 2023-01-30
• Public Version Status: New
• Public Device Record Key: 15fb9a93-82eb-4b88-a5f2-18ea97676bc1

Device Description

300 units in single package

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
KNM	Device, Pressure Applying	Physical Medicine	890.5765	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45166	Ear microsystem seed/pellet	A device used in auriculotherapy (a treatment modality in which the external surface of the ear is stimulated to alleviate pathological conditions in other parts of the body) to apply continuous pressure to stimulate meridian points. The device may be a plant seed (e.g., Vaccaria) or a metal pellet [e.g., stainless steel with or without gold (Au) or silver (Ag) plating], possibly magnetized, typically applied to the ear with adhesive tape. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04955114013124	GS1