Polyp Trap - EO sterile - Zhejiang Chuangxiang Medical Technology Co., LTD.

Duns Number:544434963

Device Description: EO sterile

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More Product Details

Catalog Number

MDPT1B0001A

Brand Name

Polyp Trap

Version/Model Number

MD-B-PT04

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

-

Product Code Details

Product Code

KDQ

Product Code Name

Bottle, Collection, Vacuum

Device Record Status

Public Device Record Key

9661154c-4866-4242-9282-e9949b61960d

Public Version Date

July 18, 2022

Public Version Number

6

DI Record Publish Date

January 09, 2019

Additional Identifiers

Package DI Number

26970401813753

Quantity per Package

5

Contains DI Package

16970401813749

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 147