TEWA - TeWa JB-Type 2030: coated acupuncture needles - asia-med GmbH

Duns Number:333450844

Device Description: TeWa JB-Type 2030: coated acupuncture needles with Japanese style, smooth metal pipe hand TeWa JB-Type 2030: coated acupuncture needles with Japanese style, smooth metal pipe handle without guide tube Packaging: 1 needle per blister Size: Gauge 3(x 1.2") / 0.20 x 30 mm Color code: light blue Sales unit: 100 pieces

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More Product Details

Catalog Number

A000782

Brand Name

TEWA

Version/Model Number

JB-Type 2030

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

K132896,K132896,K132896,K132896

Product Code Details

Product Code

MQX

Product Code Name

Needle, Acupuncture, Single Use

Device Record Status

Public Device Record Key

caf9a4e8-b342-4f44-9a0e-02b4cf0b45f1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 30, 2017

Additional Identifiers

Package DI Number

04251282513979

Quantity per Package

10

Contains DI Package

04251282513962

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

parcel

"ASIA-MED GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18