AccessGUDID - DEVICE: Nano Tech Bulk (18800018900717)

GUDID

Device Identifier (DI) Information

Brand Name: Nano Tech Bulk
Version or Model: Ntb.20x30
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Ntb.20x30
Company Name: Dong Bang Medical co.,Ltd.

Primary DI Number: 18800018900717
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 689846367 *Terms of Use

Device Description: Nano Tech™ Bulk Five Acupuncture Needles are precisely calibrated for ease and accuracy, Nano Tech™ Bulk Five needles have been completely re-engineered for a painless acupuncture experience for you and your patient. These sterile, disposable, surgical stainless steel acupuncture needles feature an easy-to-hold, color-coded 25 mm handle. The economical bulk packaging with 5 needles and one guide tube per blister package allows for easy use with less waste. Box of 500 needles (100 packs of 5 needles with tube).

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 [?]
K990328	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
Device Size Text, specify: 0.20 mm x 30 mm

Device Record Status

Public Device Record Key: f41a4d0e-8ee6-4ea6-ac03-72c46fc7d273
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 09, 2016