Catalog Number

DYNJ0101536I

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNJ0101536I

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

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

FTN

Product Code Name

Plastic surgery and accessories kit

Public Device Record Key

bd561585-7568-4c20-a30c-6506022716c9

Public Version Date

September 12, 2022

Public Version Number

1

DI Record Publish Date

September 04, 2022

Package DI Number

40195327239290

Quantity per Package

5

Contains DI Package

10195327239299

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE