VitaVitro - Shenzhen Vitavitro Bio-Tech Co.,Ltd

Duns Number:544504573

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More Product Details

Catalog Number

V015125

Brand Name

VitaVitro

Version/Model Number

Sperm Gradient Medium, 125 mL

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

K212410

Product Code Details

Product Code

MQL

Product Code Name

Media, Reproductive

Device Record Status

Public Device Record Key

7dc431fd-b050-4df9-b6b2-9f2c912980f6

Public Version Date

July 26, 2022

Public Version Number

1

DI Record Publish Date

July 18, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHENZHEN VITAVITRO BIO-TECH 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. 22