AccessGUDID - DEVICE: Alpha™ 7-Star Needle (00818318028063)

GUDID

Device Identifier (DI) Information

Brand Name: Alpha™ 7-Star Needle
Version or Model: 7-Star Needle
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NP7-01
Company Name: Prime Holly Corporation

Primary DI Number: 00818318028063
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080445043 *Terms of Use

Device Description: Plastic hammer with seven 0.2mm diameter x 2mm long needles; flexible handle is 6" long.

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):	No
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
Device Size Text, specify: 0.2mm x 2mm x 6"

Device Record Status

Public Device Record Key: d25ade7f-51de-448c-8755-4524ce141a0c
Public Version Date: November 08, 2023
Public Version Number: 3
DI Record Publish Date: January 24, 2022