NeuroTrace - Insulated Electro-Needle for use in Regional - NEO MEDICAL INC.

Duns Number:015510540

Device Description: Insulated Electro-Needle for use in Regional Anesthesia, 23ga x 3.0" (76mm), Pencil Point Insulated Electro-Needle for use in Regional Anesthesia, 23ga x 3.0" (76mm), Pencil Point / Whitacre Bevel

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More Product Details

Catalog Number

552-23-07

Brand Name

NeuroTrace

Version/Model Number

552-23-07

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Unsafe

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"

Yes

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

K032981,K032981

Product Code Details

Product Code

BSP

Product Code Name

Needle, Conduction, Anesthetic (W/Wo Introducer)

Device Record Status

Public Device Record Key

84627859-6c57-413e-8391-c4f87070d68b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

B33955223075

Quantity per Package

25

Contains DI Package

B33955223070

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"NEO MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 88