AccessGUDID - DEVICE: DBC Detox 5 (18800018900847)

GUDID

Device Identifier (DI) Information

Brand Name: DBC Detox 5
Version or Model: dtx.20x13
Commercial Distribution Status: In Commercial Distribution
Catalog Number: dtx.20x13
Company Name: Dong Bang Medical co.,Ltd.

Primary DI Number: 18800018900847
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 689846367 *Terms of Use

Device Description: DBC Detox 5 is new sterile, DBC needle 13mm in length with a highly visible plastic orange handle. Suitable for general and facial acupuncture, this needle is also great for those using the NADA protocol. The bright orange 25mm handle makes this needle easy to locate during removal or if dropped on the floor. Manufactured in an automated facility, this needle features consistency and quality unrivaled by other needles in the market. Box of 500 needles (100 packs of 5 needles).

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 13 mm

Device Record Status

Public Device Record Key: fef58875-b4bf-4d5f-bed6-dd0562549e03
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 09, 2016