Vacuum Pump Tubing - Vitrolife Sweden AB

Duns Number:631805488

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Vacuum Pump Tubing

Version/Model Number

14211

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 06, 2021

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

K991273,K991273

Product Code Details

Product Code

MQE

Product Code Name

Needle, Assisted Reproduction

Device Record Status

Public Device Record Key

1e72ebc4-dc4b-4dd0-b6f2-cb703d061959

Public Version Date

December 07, 2021

Public Version Number

4

DI Record Publish Date

September 14, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VITROLIFE SWEDEN AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 157