AccessGUDID - DEVICE: EACU, EAKU, ZAGU, JOCU (B338LJ3550R1)

GUDID

Device Identifier (DI) Information

Brand Name: EACU, EAKU, ZAGU, JOCU
Version or Model: LJ3550R
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Maanshan Bond Medical Instruments Co., Ltd.

Primary DI Number: B338LJ3550R1
Issuing Agency: HIBCC
Commercial Distribution End Date: January 03, 2030
Device Count: 100
Labeler D-U-N-S® Number*: 421257620 *Terms of Use

Device Description: No description.

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 [?]
K150903	000

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
No Device Sizes

Device Record Status

Public Device Record Key: facf5b50-6cff-41c2-8ccb-d254edf4e9b9
Public Version Date: September 21, 2023
Public Version Number: 1
DI Record Publish Date: September 13, 2023