Balance 1KS Acupuncture Needle - Featuring a traditional “spring” style handle - BLUE POPPY ENTERPRISES INC.

Duns Number:080493003

Device Description: Featuring a traditional “spring” style handle that comes in blister packs of 10 needles an 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.

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More Product Details

Catalog Number

-

Brand Name

Balance 1KS Acupuncture Needle

Version/Model Number

Balance 1KS-Type 2540

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K150903,K150903

Product Code Details

Product Code

MQX

Product Code Name

Needle, acupuncture, single use

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-