Vasc Band - Lepu Medical Technology (Beijing) Co.,Ltd.

Duns Number:529853921

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More Product Details

Catalog Number

-

Brand Name

Vasc Band

Version/Model Number

3521

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 27, 2016

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

DXC

Product Code Name

Clamp, Vascular

Device Record Status

Public Device Record Key

1036b730-5343-4c05-8a0e-7693732c7c95

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

26936733770324

Quantity per Package

10

Contains DI Package

06936733770320

Package Discontinue Date

October 27, 2016

Package Status

Not in Commercial Distribution

Package Type

-

"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