Catalog Number

ACD01-E

Brand Name

Amnicot

Version/Model Number

Amnicot English

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K850758,K850758,K850758,K850758

Product Code

HGE

Product Code Name

Amniotome

Public Device Record Key

50eafec5-2799-4281-baa8-55c499b33e04

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

9350902000204

Quantity per Package

5200

Contains DI Package

09350902000174

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer carton