AccessGUDID - DEVICE: Magrain Conical Pellets with Tan Color Tape, without pack (04955114013162)

GUDID

Device Identifier (DI) Information

Brand Name: Magrain Conical Pellets with Tan Color Tape, without pack
Version or Model: 8010151
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SAKAMURA KENKYUSHO, K.K.

Primary DI Number: 04955114013162
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 703091116 *Terms of Use

Device Description: 50 in single pack

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNM	Device, Pressure Applying

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 84977937-e922-4c3c-b18c-ce4ce95ad9bd
Public Version Date: June 20, 2023
Public Version Number: 1
DI Record Publish Date: June 12, 2023