Catalog Number

MI00625

Brand Name

Argyle

Version/Model Number

MI00625

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"

-

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

FOK

Product Code Name

PAD, NEONATAL EYE

Public Device Record Key

39440848-a4c7-4895-affd-1cc8aaf3b3a8

Public Version Date

March 21, 2019

Public Version Number

3

DI Record Publish Date

June 27, 2018

Package DI Number

20884527020031

Quantity per Package

50

Contains DI Package

10884527020034

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE