KIPIC® Sterile hypodermic needle for single use - Disposable needle for hypodermic injections - AESTHETIC GROUP

Duns Number:260069352

Device Description: Disposable needle for hypodermic injections

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More Product Details

Catalog Number

KIPIC33G08

Brand Name

KIPIC® Sterile hypodermic needle for single use

Version/Model Number

33G x 8 mm

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)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Device Record Status

Public Device Record Key

627b17fe-3c71-46e0-8329-d1301ad8d2eb

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

November 30, 2019

Additional Identifiers

Package DI Number

03760173231621

Quantity per Package

10000

Contains DI Package

03760173231614

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"AESTHETIC GROUP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 92
2 A medical device with a moderate to high risk that requires special controls. 49