DEWIN - Dewin Fertilization Medium without HSA. 25mL. - DonneVie Medical Technology(Shanghai)Co.Ltd

Duns Number:554479334

Device Description: Dewin Fertilization Medium without HSA. 25mL.

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More Product Details

Catalog Number

-

Brand Name

DEWIN

Version/Model Number

9342

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

K212426

Product Code Details

Product Code

MQL

Product Code Name

Media, Reproductive

Device Record Status

Public Device Record Key

c1173b18-fa50-47f9-9876-7b8528b39997

Public Version Date

July 18, 2022

Public Version Number

1

DI Record Publish Date

July 08, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DONNEVIE MEDICAL TECHNOLOGY(SHANGHAI)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. 10