Cyst Puncture Needle without Stylet - Vitrolife Sweden AB

Duns Number:631805488

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More Product Details

Catalog Number

-

Brand Name

Cyst Puncture Needle without Stylet

Version/Model Number

14814

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 24, 2017

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

K862365,K862365

Product Code Details

Product Code

KNA

Product Code Name

Instrument, Manual, Specialized Obstetric-Gynecologic

Device Record Status

Public Device Record Key

f562153e-909a-4571-9ca5-ee507c5dafdb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 14, 2016

Additional Identifiers

Package DI Number

17350025912414

Quantity per Package

5

Contains DI Package

07350025912417

Package Discontinue Date

February 24, 2017

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