Catalog Number

DYNJRA2028

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNJRA2028

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

OFT

Product Code Name

Spinal epidural anesthesia kit

Public Device Record Key

62449890-8526-474e-8605-21191b03a7b1

Public Version Date

September 05, 2022

Public Version Number

1

DI Record Publish Date

August 28, 2022

Package DI Number

40195327226290

Quantity per Package

30

Contains DI Package

10195327226299

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE