VitaVitro - Shenzhen Vitavitro Bio-Tech Co.,Ltd

Duns Number:544504573

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More Product Details

Catalog Number

V002001, V002002

Brand Name

VitaVitro

Version/Model Number

LD-1.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 05, 2026

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

K180073

Product Code Details

Product Code

MQL

Product Code Name

Media, Reproductive

Device Record Status

Public Device Record Key

1e326606-aa29-4955-89d4-4c7bbe733147

Public Version Date

February 22, 2021

Public Version Number

3

DI Record Publish Date

December 05, 2018

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