AccessGUDID - DEVICE: Balance 1KS Acupuncture Needle (10854166000742)

GUDID

Device Identifier (DI) Information

Brand Name: Balance 1KS Acupuncture Needle
Version or Model: Balance 1KS-Type 2540
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BLUE POPPY ENTERPRISES INC.

Primary DI Number: 10854166000742
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1000
Labeler D-U-N-S® Number*: 080493003 *Terms of Use

Device Description: Featuring a traditional “spring” style handle that comes in blister packs of 10 needles and one guide tube, the Balance 1KS is an achievement in combining the highest quality with unprecedented value.

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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 0.25 Millimeter
Length: 40 Millimeter

Device Record Status

Public Device Record Key: 7c8e0ae2-7408-4b1b-b8e4-b5c53eb5a0bc
Public Version Date: February 11, 2019
Public Version Number: 1
DI Record Publish Date: January 09, 2019