Catalog Number

M2616D25

Brand Name

DeRoyal

Version/Model Number

M2616D25

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

IKX

Product Code Name

AID, TRANSFER

Public Device Record Key

66ba59d6-66f5-4583-b829-8983e0f17aaa

Public Version Date

August 11, 2021

Public Version Number

1

DI Record Publish Date

August 03, 2021

Package DI Number

50749756281930

Quantity per Package

25

Contains DI Package

00749756281935

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case