AccessGUDID - DEVICE: SEIRIN ACUPUNCTURE NEEDLE (04547248210403)

GUDID

Device Identifier (DI) Information

Brand Name: SEIRIN ACUPUNCTURE NEEDLE
Version or Model: L-Type No.5(0.25)x40mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SEIRIN CORPORATION

Primary DI Number: 04547248210403
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 693307373 *Terms of Use

Device Description: The Laser sharp L-Type needles from SEIRIN offer practitioners a painless choice for moxibustion or electro-therapy treatments. The L-Type features a flexible 1.3 x 20 mm metal spring type handle, optimal for conducting electricity and heat during use. It also provides the practitioner with an enhanced grip, for a precise treatment. Made up entirely of surgical stainless steel, the L-Type upholds SEIRIN's long tradition of innovation, quality, and safety. Each needle comes individually packaged with its own polypropylene guide tube, which is rounded on the end for patient comfort and is 100% PVC free. Box of 100 sterile, disposable needles.

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
Length: 40 Millimeter
Outer Diameter: 0.25 Millimeter

Device Record Status

Public Device Record Key: 01b5bcb9-9943-4e78-a491-21df97dcfe5d
Public Version Date: April 22, 2024
Public Version Number: 5
DI Record Publish Date: December 19, 2016