Tuohy Epidural Needle - 18 ga (1.3mm) x 9 cm - REMINGTON MEDICAL, INC.

Duns Number:788472314

Device Description: 18 ga (1.3mm) x 9 cm

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More Product Details

Catalog Number

TNMF-1803

Brand Name

Tuohy Epidural Needle

Version/Model Number

TNMF-1803

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

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Device Record Status

Public Device Record Key

565b130c-5bb7-407b-a6f3-4136cec7618c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

10813079021015

Quantity per Package

10

Contains DI Package

00813079021018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton

"REMINGTON MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 22
2 A medical device with a moderate to high risk that requires special controls. 32