Shoocin - The ShoocinTM Introducer Kit consists of a - Lepu Medical Technology (Beijing) Co.,Ltd.

Duns Number:529853921

Device Description: The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire

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More Product Details

Catalog Number

-

Brand Name

Shoocin

Version/Model Number

RS061118S

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"

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

-

Product Code Details

Product Code

DYB

Product Code Name

Introducer, Catheter

Device Record Status

Public Device Record Key

81f1978d-e5bd-452d-81bb-381a5a3258fd

Public Version Date

June 07, 2019

Public Version Number

2

DI Record Publish Date

September 02, 2018

Additional Identifiers

Package DI Number

16936733740160

Quantity per Package

5

Contains DI Package

06936733740163

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"LEPU MEDICAL TECHNOLOGY (BEIJING) CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 89