IMPROVACUTER® Gel & Clot Activator Tube - Guangzhou Improve Medical Instruments Co., Ltd.

Duns Number:554555378

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More Product Details

Catalog Number

-

Brand Name

IMPROVACUTER® Gel & Clot Activator Tube

Version/Model Number

13×75mm,3ml

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K093910,K093910,K093910

Product Code Details

Product Code

JKA

Product Code Name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Device Record Status

Public Device Record Key

f00f5414-06d5-4c45-b7ec-f6e973251b6d

Public Version Date

July 04, 2022

Public Version Number

1

DI Record Publish Date

June 24, 2022

Additional Identifiers

Package DI Number

46974481831380

Quantity per Package

10

Contains DI Package

16974481831389

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"GUANGZHOU IMPROVE MEDICAL INSTRUMENTS 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. 32