AccessGUDID - DEVICE: SEIRIN ACUPUNCTURE NEEDLE (04547248140045)

GUDID

Device Identifier (DI) Information

Brand Name: SEIRIN ACUPUNCTURE NEEDLE
Version or Model: ELIPEAS No.02(0.12)x7mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SEIRIN CORPORATION

Primary DI Number: 04547248140045
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 693307373 *Terms of Use

Device Description: ELIPEAS is perfect for facial, auricular acupuncture especially treating the body parts where needles inserted superficially. Stabled needle retention with less-weighed-handle. ELIPEAS is available only in a length of 7mm and does not have guide tubes, which makes it ideal for freehand techniques. 4 needles per plastic case. This plastic case not only preserves the needle but also converts into both standing and portable functional dispenser by folding it. The color-coded 18 mm plastic handle gives the practitioner a secure grip. 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
Outer Diameter: 0.12 Millimeter
Length: 7 Millimeter

Device Record Status

Public Device Record Key: ac0112e3-e204-4d7b-a39a-4c82015a3938
Public Version Date: April 22, 2024
Public Version Number: 3
DI Record Publish Date: August 25, 2021