LCCS - AN-E EPIDURAL NEEDLE - LCCS Products Limited

Duns Number:663190222

Device Description: AN-E EPIDURAL NEEDLE

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More Product Details

Catalog Number

-

Brand Name

LCCS

Version/Model Number

ET20113-LC

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

K131006,K131006,K131006

Product Code Details

Product Code

BSP

Product Code Name

Needle, Conduction, Anesthetic (W/Wo Introducer)

Device Record Status

Public Device Record Key

05b93281-0c59-4cc4-b24a-d5fd94d0af2e

Public Version Date

August 02, 2021

Public Version Number

1

DI Record Publish Date

July 24, 2021

Additional Identifiers

Package DI Number

14895233608122

Quantity per Package

25

Contains DI Package

04895233608125

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"LCCS PRODUCTS LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 46