AccessGUDID - DEVICE: SEIRIN SPINEX NEEDLE (04547248500023)

GUDID

Device Identifier (DI) Information

Brand Name: SEIRIN SPINEX NEEDLE
Version or Model: NS No.02(0.12)x4mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SEIRIN CORPORATION

Primary DI Number: 04547248500023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 693307373 *Terms of Use

Device Description: An essential part of cosmetic acupuncture and other treatment modalities, Spinex™ intradermal needles (hinai-shin) provide you with a high quality option for specialized acupuncture treatments. These individually packaged, disposable needles are made entirely of surgical stainless steel. The heat-sealed blister package ensures sterility, while the perforated tear-off strip makes them easy to use. With a ring handle measuring 1.5mm in diameter, Spinex™ is available in 3 different lengths. To use, simply open the blister package, grip the head of the needle with tweezers, remove and insert. One sterile needle per blister package. Box of 100 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: 4 Millimeter

Device Record Status

Public Device Record Key: 57f34050-a760-41f8-8f04-aadbc69c33d6
Public Version Date: April 22, 2024
Public Version Number: 5
DI Record Publish Date: September 12, 2016