N/A - Huber Needle - Obtech Medical Sàrl

Duns Number:486911852

Device Description: Huber Needle

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More Product Details

Catalog Number

RHUB90

Brand Name

N/A

Version/Model Number

RHUB90

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 06, 2018

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

GAA

Product Code Name

NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Device Record Status

Public Device Record Key

3828709e-7995-4b36-a102-311c92a09d27

Public Version Date

January 08, 2021

Public Version Number

3

DI Record Publish Date

July 15, 2016

Additional Identifiers

Package DI Number

30705036011792

Quantity per Package

750

Contains DI Package

20705036011795

Package Discontinue Date

February 06, 2018

Package Status

Not in Commercial Distribution

Package Type

CASE

"OBTECH MEDICAL SÀRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 2
3 A medical device with high risk that requires premarket approval 2