Catalog Number

AR200

Brand Name

AROM-COT

Version/Model Number

Medium

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HGE

Product Code Name

Amniotome

Public Device Record Key

470a310b-9fea-42fe-a79b-397d2d734bb2

Public Version Date

June 12, 2020

Public Version Number

1

DI Record Publish Date

June 04, 2020

Package DI Number

H671AR2001

Quantity per Package

100

Contains DI Package

H671AR2000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-