Catalog Number

-

Brand Name

Amielle

Version/Model Number

SM 2100

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

-

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

K983045,K983045

Product Code

KXP

Product Code Name

Stent, Vaginal

Public Device Record Key

6f1c6a04-a108-48a0-af36-11e6b4d70b66

Public Version Date

September 02, 2021

Public Version Number

4

DI Record Publish Date

September 19, 2016

Package DI Number

00384702100030

Quantity per Package

25

Contains DI Package

00384702100016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case