Cyst Puncture Needle with Stylet - Vitrolife Sweden AB

Duns Number:631805488

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More Product Details

Catalog Number

-

Brand Name

Cyst Puncture Needle with Stylet

Version/Model Number

17809

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 27, 2020

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

KNA

Product Code Name

Instrument, Manual, Specialized Obstetric-Gynecologic

Device Record Status

Public Device Record Key

02b0d7b1-a44c-4ed5-897d-6373f2d745e1

Public Version Date

February 09, 2021

Public Version Number

3

DI Record Publish Date

January 09, 2018

Additional Identifiers

Package DI Number

17350025915606

Quantity per Package

10

Contains DI Package

07350025915609

Package Discontinue Date

February 27, 2020

Package Status

Not in Commercial Distribution

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