AccessGUDID - DEVICE: HBW A ONE (00816073021169)

GUDID

Device Identifier (DI) Information

Brand Name: HBW A ONE
Version or Model: A Type No.32G x 40mm(1.5")
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AA3215
Company Name: HEALTH BODY WORLD SUPPLY, INC.

Primary DI Number: 00816073021169
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 061228290 *Terms of Use

Device Description: Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:32Gauge x 40mm (1.5")

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):	Yes

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: No 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: 0.25 x 40mm

Device Record Status

Public Device Record Key: a35fd0ec-32e3-40c9-aee9-c150c9be680b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 09, 2016