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

ET2290-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

fbad45b1-429f-4d61-97a3-6018951bdaeb

Public Version Date

January 09, 2020

Public Version Number

1

DI Record Publish Date

January 01, 2020

Additional Identifiers

Package DI Number

64895233608011

Quantity per Package

40

Contains DI Package

14895233608016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton

"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