AccessGUDID - DEVICE: AcuZone (B491AZ18405)

GUDID

Device Identifier (DI) Information

Brand Name: AcuZone
Version or Model: AZ-1840
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AZ-1840
Company Name: Wujiang City ShenLing Medical Device Co.,Ltd

Primary DI Number: B491AZ18405
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1000
Labeler D-U-N-S® Number*: 654613546 *Terms of Use

Device Description: Smooth and sharp for painless, AcuZone disposable sterile acupuncture needles are made of high quality surgical stainless steel and the handle is without loop. Steriliized with Ethylene Oxide, This is a bulk pack offering a more economical price. 10 needles with one (insertion) guide tube per sterile, individually sealed blister package. Box of 1000 needles. 0.18mm x 40mm (38# x 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):	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: 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: Needle Size 0.18mm x 40mm

Device Record Status

Public Device Record Key: 489f6686-3824-4308-a0c7-40578b5a7013
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 21, 2017