Catalog Number

-

Brand Name

Amielle Restore

Version/Model Number

SM 3100

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HDQ

Product Code Name

Dilator, Cervical, Fixed Size

Public Device Record Key

71024039-ae68-4432-b40a-117d7a685129

Public Version Date

October 21, 2022

Public Version Number

2

DI Record Publish Date

September 15, 2022

Package DI Number

00038470310039

Quantity per Package

25

Contains DI Package

00384703100015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case