Catalog Number

-

Brand Name

Follicle Aspiration needle - single lumen

Version/Model Number

#4551 FAS XD-BCB2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K013497,K013497,K013497

Product Code

MQE

Product Code Name

Needle, Assisted Reproduction

Public Device Record Key

056c5d04-d074-49b0-ad70-6da00519a83e

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

November 03, 2016

Package DI Number

25425017505840

Quantity per Package

50

Contains DI Package

05425017505846

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-