HBW HI.CHI - The ergonomically optimized and precisely - HEALTH BODY WORLD SUPPLY, INC.

Duns Number:061228290

Device Description: The ergonomically optimized and precisely centered handle ensures safe and convenient use. The ergonomically optimized and precisely centered handle ensures safe and convenient use. Measuring 2.0 x 20 mm, the handle is made of extremely lightweight and environmentally-friendly polypropylene plastic with Color-coded handles for easy gauge identification. Light Touch Insertion, the needle is easily released from its guide tube by gently pressing the needle away from its point of attachment on the tube, easy peel-open blister packaging. The needle is made of the highest quality surgical stainless steel. At the tip, it is filed to diamond sharpness and polished, making insertion particularly easy for the therapist and practically painless for the patient. Box of 100. Size: 30G x 50mm.

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More Product Details

Catalog Number

HP3020

Brand Name

HBW HI.CHI

Version/Model Number

HP Type No.30G x 50mm

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

Yes

FDA Premarket Submission

-

Product Code Details

Product Code

MQX

Product Code Name

Needle, Acupuncture, Single Use

Device Record Status

Public Device Record Key

8bebc8ae-4b39-4cc8-938d-0d504acf7333

Public Version Date

September 17, 2019

Public Version Number

1

DI Record Publish Date

September 09, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HEALTH BODY WORLD SUPPLY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 51