AccessGUDID - DEVICE: SEIRIN ACUPUNCTURE NEEDLE (04547248171117)

GUDID

Device Identifier (DI) Information

Brand Name: SEIRIN ACUPUNCTURE NEEDLE
Version or Model: J-ProPak10 No.1(0.16)x30mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SEIRIN CORPORATION

Primary DI Number: 04547248171117
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 693307373 *Terms of Use

Device Description: The world's most popular acupuncture needle is now available in a user-friendly 10-pack. J-ProPak® 10 needles are made from the highest quality stainless steel and feature a lightweight, comfort grip, 2.0 x 20 mm plastic handle that is color coded for easy gauge identification. It continues the J-Type's tradition of gentle, painless and stress-free acupuncture but also features an easy open multi-pack, that allows for easy access to 10 needles at a time. The J-ProPak® 10 blister pack also converts into a functional dispenser that can rest on a treatment tray or other surface, keeping the needles sterile and easily accessible during treatment. Each blister pack contains 10 plastic handle needles and one polypropylene guide tube. Box of 100.

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34175	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.	Active	false

FDA Product Code

[?]

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

[?]

Size Type Text
Outer Diameter: 0.16 Millimeter
Length: 30 Millimeter

Device Record Status

Public Device Record Key: 5cf47610-3355-4be2-a510-617e3e70eb25
Public Version Date: April 22, 2024
Public Version Number: 5
DI Record Publish Date: December 19, 2016