AccessGUDID - DEVICE: SEIRIN PYONEX (04547248420031)

GUDID

Device Identifier (DI) Information

Brand Name: SEIRIN PYONEX
Version or Model: Pyonex Green 0.17x0.9mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SEIRIN CORPORATION

Primary DI Number: 04547248420031
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 693307373 *Terms of Use

Device Description: Designed with both the patient and practitioner in mind, the new and advanced Pyonex™ Singles continue SEIRIN's tradition of gentle, painless and stress free press needles. The patented plastic case and sheath allow the practitioner to insert the needle without touching the needle tip or the surface of the Micropore adhesive tape. This hypoallergenic latex-free adhesive allows the skin to breathe during treatment. With SEIRIN's consistently smooth insertion, the result is a pleasant and painless experience for your patient.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Acupuncture needle, single-use	A sterile, long, slender, sharply-pointed instrument used to stimulate peripheral nerves in order to produce surgical anaesthesia, relieve pain, and to promote other therapeutic effects. It is widely used in complementary therapy. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
MQX	Needle, Acupuncture, Single Use

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: Yes
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

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Size Type Text
Outer Diameter: 0.17 Millimeter
Length: 0.9 Millimeter

Device Record Status

Public Device Record Key: bf65f9b2-d01b-435a-a657-163d1e75813c
Public Version Date: June 04, 2018
Public Version Number: 3
DI Record Publish Date: August 22, 2017