AccessGUDID - DEVICE: Dana Long Acupuncture needle Pouch 10T (08800023302141)

GUDID

Device Identifier (DI) Information

Brand Name: Dana Long Acupuncture needle Pouch 10T
Version or Model: ANS40-12030
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DANA medical.co.ltd

Primary DI Number: 08800023302141
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 689851191 *Terms of Use

Device Description: Dana Long Acupuncture Needles are high quality bulk packaged needles in Pouches. Dana Long Acupuncture Needles are manufactured by Dana Medical Co., Ltd. with the most advanced automatic manufacturing facility of Acupuncture needles in Korea with Excellent needle tip polishing technology allowing you smooth insertion feeling of needles into patient's body. Dana Long Acupuncture Needle Pouch 10T contains 10 needles with 1 guide tube per sterile pouch packages in a Box of 500 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):	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: Yes 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: a253a040-db7f-4dcd-ad3a-84517c30f557
Public Version Date: October 14, 2021
Public Version Number: 4
DI Record Publish Date: December 29, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
08800023302066	50	08800023302141	In Commercial Distribution	Small inner box
08800023302059	2	08800023302066	In Commercial Distribution	Middle inner box
08800023302042	10	08800023302059	In Commercial Distribution	Carton box