Catalog Number

72-7100NS

Brand Name

DeRoyal

Version/Model Number

72-7100NS

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

-

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

b4964eda-56e5-4b7c-8d08-449d9ac34374

Public Version Date

July 20, 2021

Public Version Number

1

DI Record Publish Date

July 12, 2021

Package DI Number

50749756166374

Quantity per Package

500

Contains DI Package

00749756166379

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case