Spine Needle (16 Gauge) - ELLIQUENCE, LLC

Duns Number:019872358

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More Product Details

Catalog Number

-

Brand Name

Spine Needle (16 Gauge)

Version/Model Number

DFX-N6/1

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

-

Product Code Details

Product Code

BSP

Product Code Name

Needle, Conduction, Anesthetic (W/Wo Introducer)

Device Record Status

Public Device Record Key

75a2288f-6a48-4632-a05f-8199d4b0cc3c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

00846338001315

Quantity per Package

10

Contains DI Package

00846338008017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box (DFX-N6)

"ELLIQUENCE, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 98